Phase 2a, AMP Challenge, Dose Escalation Study to Assess... | NCT02991859 | Trialant
NCT02991859
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jul 31, 2020Actual
Enrollment
56Actual
Phase
Phase 2
Conditions
Asthma
Interventions
Fluticasone furoate (FF) Dry Powder Inhaler
Fluticasone propionate (FP) Dry Powder Inhaler
Budesonide (BUD) Turbuhaler
Placebo (ELLIPTA or DISKUS)
Countries
Germany
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02991859
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
203162
Secondary IDs
ID
Type
Description
Link
2016-003002-14
EudraCT Number
Brief Title
Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects
Official Title
An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate (AMP) Challenge and the Dose Response for Systemic Activity Via 24h Plasma Cortisol Suppression and Thereby the Relative Therapeutic Index for Fluticasone Furoate (FF), Fluticasone Propionate (FP) and Budesonide (BUD) in Asthmatic Subjects
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 9, 2017Actual
Primary Completion Date
Dec 20, 2018Actual
Completion Date
Dec 20, 2018Actual
First Submitted Date
Dec 9, 2016
First Submission Date that Met QC Criteria
Dec 9, 2016
First Posted Date
Dec 14, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2019
Results First Submitted that Met QC Criteria
Mar 26, 2020
Results First Posted Date
Mar 30, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 14, 2020
Last Update Posted Date
Jul 31, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study, aiming to investigate whether higher potency of different inhaled corticosteroid confers an improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will compare the dose response for topical efficacy via airway responsiveness (to adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via 24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD). There will be a screening visit 4 - 42 days before the first dose of study treatment, and AMP challenge Provocative concentration 20 (PC20) of <=80 milligrams per milliliter (mg/mL) at screening visit 2 i.e. at 4 - 14 days before the first dose of study treatment. Subjects will be randomized to one of 5 or 12 treatment sequences, and will have one or two treatment periods, each comprising 5 consecutive 7-day phases of escalating doses of either FF, FP, BUD or placebo. There will be a 25- to 42-day washout period between treatment periods. The study duration for each subject will be approximately 13 or 24 weeks including the follow-up period.
Detailed Description
Not provided
Conditions Module
Conditions
Asthma
Keywords
Dose-response
AMP challenge
cortisol suppression
dose escalation
therapeutic index
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
56Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm AB - FF followed by FP
Experimental
Each treatment period (TP) comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or FP. In TP 1, subjects will receive evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or BUD. In TP 1, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD = 100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD = 1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.
Drug: Fluticasone furoate (FF) Dry Powder Inhaler
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fluticasone furoate (FF) Dry Powder Inhaler
Drug
Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis
The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.
Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.
Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
Theraputic Index of FF
Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria - Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed Consent. - Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit - Pre-bronchodilator FEV1 >=65% of predicted at screening; the pre-dose baseline FEV1 should not have changed significantly in the opinion of the investigator from the screening baseline value and should be >=65% predicted for the subject to continue - Documented sensitivity to AMP with a provocative concentration of AMP resulting in a fall of >=20% FEV1 with a PC20 AMP <=80 mg/mL at the screening visit - Current therapy could include short-acting Beta2-agonists (SABA) prescribed SABA for at least 12 weeks prior to screening, if needed; subjects receiving low-dose ICS may take part after a 4-week ICS washout prior to AMP challenge. The subject's asthma symptoms must remain stable during this 4-week period as assessed at screening visit 2. Stable asthma is defined as no more than 2 consecutive days where >=12 inhalations/day of salbutamol were used; or no severe asthma exacerbations requiring use of systemic corticosteroids (tablets, suspension, or injection) or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids; or no clinical asthma worsening which in the opinion of the investigator requires additional asthma treatment other than study medication or salbutamol; subjects taking Long-acting beta2-agonist (LABA), long-acting muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA) therapy within three months prior to the start of the study are not eligible; subjects taking biological therapies within 6 months prior to start of the study are not eligible. - Bodyweight >=50 Kilogram (kg) and BMI within the range 18.0-35.0 kg/meter (m)^2 (inclusive) - Male and female. Females: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [HCG] test), not lactating, and at least one of the following conditions applies prior to randomization: • Non-reproductive potential defined as pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea, in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. • Reproductive potential and agrees to follow one of the highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until at least five terminal half-lives after the last dose of study medication. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Aspartate aminotransferase and Alanine transaminase <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤1.5 x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) - Light smokers, who smoke <=20 cigarettes per week or equivalent unit dose of other tobacco products or e-cigarettes, are eligible for the study. Smokers who intend to stop, reduce or increase their smoking habit during the study period are not eligible. - Having provided written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria: - A history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years. - Other significant pulmonary diseases to include (but not limited to) severe pneumonia within 6 months of the screening visit, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma. - Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of screening that: In the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. - A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening. - Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to randomization. - Use of prohibited medications including, anti-depressant drugs, and anti-asthma drugs (other than short acting inhaled beta-agonists supplied as rescue medication, oral contraceptives, non-steroidal anti-inflammatory drugs, stable doses of antihistamines, and paracetamol) for 1 week prior to screening and throughout the course of the study. Anti-histamines should be withheld 4 days prior to AMP challenge; subjects must also be able to abstain from short acting inhaled beta-agonists, for 8 hours prior to spirometry. - Subjects undergoing de-sensitization therapy - Current smokers who smoke > 20 cigarettes per week or the equivalent unit dose of other tobacco products or e-cigarettes, or smokers with a smoking history of >=10 pack years. - History of regular alcohol consumption exceeding 21 units per week for men and 14 units per week for females (1 unit =5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of spirits) within 6 months of screening. - All subjects who are currently or in the last month have worked night-shifts are excluded from the study - Exposure to more than four new chemical entities within 12 months prior to the first dosing day or received an investigational product within 30 days of study start, or 5 half-lives of study drug if that is longer. - A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study. (e.g. stroke or myocardial infarction within 3 months, uncontrolled hypertension, congestive heart failure, uncontrolled diabetes mellitus.) - Evidence of cancer or history of cancer in the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. - Pregnant females as determined by positive urine HCG test at screening or by positive urine HCG test prior to dosing and lactating females. - Subjects with active or chronic infections including hepatitis B or C, human immunodeficiency virus. A positive serology at screening. - Allergies: History of severe milk protein allergy Drug Allergy defined as any adverse reaction including immediate or delayed hypersensitivity to intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of FF, FP or BUD (i.e., lactose or magnesium stearate etc.) Historical Allergy defined as history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - Significant abnormality in the 12-lead electrocardiogram (ECG) performed at screening. The mean of the three individual ECGs will be taken. Mean QT interval corrected for heart rate (QTc) >450 millisecond (msec) for males or QTc>470 msec for female subjects and >480 in subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF).
Daley-Yates P, Brealey N, Thomas S, Austin D, Shabbir S, Harrison T, Singh D, Barnes N. Therapeutic index of inhaled corticosteroids in asthma: A dose-response comparison on airway hyperresponsiveness and adrenal axis suppression. Br J Clin Pharmacol. 2021 Feb;87(2):483-493. doi: 10.1111/bcp.14406. Epub 2020 Jun 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 165 participants were screened of which 109 failed screening and 56 participants were enrolled in study. Of the 56 participants enrolled,only 54 were randomized and received at least one dose of study medication. Only 7 participants were withdrawn from the study, 2 participants who were not withdrawn, entered Period 2 esc Phase 1.
Recruitment Details
A total of 56 participants were enrolled across 1 center in Germany and 2 centers in the United Kingdom.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm AB - FF Followed by FP
Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or ELLIPTA Placebo. In TP 1, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period will be of 25-42 days.
Drug: Fluticasone furoate (FF) Dry Powder Inhaler
Drug: Placebo (ELLIPTA or DISKUS)
Arm BA - FP followed by FF
Experimental
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or FF. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or BUD. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or DISKUS Placebo. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Each TP will be followed by a washout period of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or FF. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.
Drug: Fluticasone furoate (FF) Dry Powder Inhaler
Drug: Budesonide (BUD) Turbuhaler
Arm CB - BUD followed by FP
Experimental
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or FP. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or DISKUS Placebo. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; and AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period will be of 25-42 days.
Drug: Budesonide (BUD) Turbuhaler
Drug: Placebo (ELLIPTA or DISKUS)
Arm DA - ELLIPTA Placebo followed by FF
Experimental
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either ELLIPTA Placebo or FF. In TP 1, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.
Drug: Fluticasone furoate (FF) Dry Powder Inhaler
Drug: Placebo (ELLIPTA or DISKUS)
Arm EB - DISKUS Placebo followed by FP
Experimental
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either DISKUS Placebo or FP. TP 1, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.
Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either ELLIPTA Placebo or BUD. In TP 1, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.
Drug: Budesonide (BUD) Turbuhaler
Drug: Placebo (ELLIPTA or DISKUS)
Arm AB - FF followed by FP
Arm AC - FF followed by BUD
Arm AD - FF followed by ELLIPTA Placebo
Arm BA - FP followed by FF
Arm CA - BUD followed by FF
Arm DA - ELLIPTA Placebo followed by FF
Fluticasone propionate (FP) Dry Powder Inhaler
Drug
Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods
Arm AB - FF followed by FP
Arm BA - FP followed by FF
Arm BC - FP followed by BUD
Arm BE - FP followed by DISKUS Placebo
Arm CB - BUD followed by FP
Arm EB - DISKUS Placebo followed by FP
Budesonide (BUD) Turbuhaler
Drug
Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods.
Arm AC - FF followed by BUD
Arm BC - FP followed by BUD
Arm CA - BUD followed by FF
Arm CB - BUD followed by FP
Arm CE - BUD followed by DISKUS Placebo
Arm DC - ELLIPTA Placebo followed by BUD
Placebo (ELLIPTA or DISKUS)
Drug
Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.
Arm AD - FF followed by ELLIPTA Placebo
Arm BE - FP followed by DISKUS Placebo
Arm CE - BUD followed by DISKUS Placebo
Arm DA - ELLIPTA Placebo followed by FF
Arm DC - ELLIPTA Placebo followed by BUD
Arm EB - DISKUS Placebo followed by FP
Theraputic Index of FP
Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
Theraputic Index of BUD
Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
Up to Week 18
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.
Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 2,3,4,5,6,7 PM in period 1
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 2,3,4,5,6,7 PM in period 2
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 8,9,10,11,12,13,14 PM in period 1
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 8,9,10,11,12,13,14 PM in period 2
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 15,16,17,18,19,20,21 PM in period 1
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Days 22,23,24,25,26,27,28 PM in period 1
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Days 22,23,24,25,26,27,28 PM in period 2
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Days 29,30,31,32,33,34,35 PM in period 1
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 29,30,31,32,33,34,35 PM in period 2
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 2,3,4,5,6,7 PM in period 1
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 2,3,4,5,6,7 AM and PM in period 2
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Days 8,9,1,0,11,12,13,14 AM and PM in period 1
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 8,9,1,0,11,12,13,14 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 2 to 6 AM and PM, Day 7 PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 2,3,4,5,6,7 PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 8 PM, Day 9 to 14 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 8 PM, Day 9 to 14 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2
Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Up to Week 18
Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate
Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Up to Week 18
Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate
Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Up to Week 18
Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature
Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Up to Week 18
Number of Participants With Abnormal Physical Examination
Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.
Up to Week 18
Number of Participants With Clinically Significant Abnormal Hematology Parameters
Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.
Up to Week 18
Number of Participants With Clinically Significant Abnormal Chemistry Parameters
Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.
Up to Week 18
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters
Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.
Up to Week 18
Forced Expiratory Volume in 1 Second (FEV 1) in Period 1
FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.
Day 1 (pre-dose) in Period 1
Forced Expiratory Volume in 1 Second (FEV 1) in Period 2
FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
Day 1 (pre-dose) in Period 2
Forced Vital Capacity (FVC) in Period 1
FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
Day 1 (pre-dose) in Period 1
Forced Vital Capacity (FVC) in Period 2
FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
Day 1 (pre-dose) in Period 2
Harrow
Middlesex
HA1 3UJ
United Kingdom
GSK Investigational Site
Manchester
M23 9QZ
United Kingdom
FG001
Arm AC - FF Followed by BUD
Participants received PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period was of 25-42 days.
FG002
Arm AD - FF Followed by ELLIPTA Placebo
Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
FG003
Arm BA - FP Followed by FF
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
FG004
Arm BC - FP Followed by BUD
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
FG005
Arm BE - FP Followed by DISKUS Placebo
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
FG006
Arm CA - BUD Followed by FF
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
FG007
Arm CB - BUD Followed by FP
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
FG008
Arm CE - BUD Followed by DISKUS Placebo
Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
FG009
Arm DA - ELLIPTA Placebo Followed by FF
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
FG010
EB - DISKUS Placebo Followed by FP
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
FG011
Arm DC - ELLIPTA Placebo Followed by BUD
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
FG012
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
FG013
Fluticasone Propionate (FP)
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
FG014
Budesonide (BUD)
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
FG015
ELLIPTA
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
FG016
DISKUS
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0127 subjects
FG0137 subjects
FG0146 subjects
FG0153 subjects
FG0163 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0053 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0127 subjects
FG0137 subjects
FG0146 subjects
FG0153 subjects
FG0163 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Period 1,Escalation Phase2,Upto Day 14
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0053 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0127 subjects
FG0137 subjects
FG0146 subjects
FG0153 subjects
FG0163 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period1, Escalation Phase3, Upto Day21
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0053 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0127 subjects
FG0137 subjects
FG0146 subjects
FG0153 subjects
FG0163 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period1, Escalation Phase4, Upto Day28
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects1 Par completed Phase 3 did not enter Phase 4
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0126 subjects
FG0136 subjects
FG0146 subjects
FG0153 subjects
FG0163 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period1, Escalation Phase5, Upto Day35
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0101 subjects1 participant did not enter Esc Phase 5, and was not withdrawn
FG0112 subjects
FG0126 subjects
FG0136 subjects
FG0146 subjects
FG0153 subjects
FG0163 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Wash Out, Up to Day 77
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0101 subjects
FG0112 subjects
FG0120 subjectsParticipants did not enter washout and Period 2
FG0130 subjectsParticipants did not enter washout and Period 2
FG0140 subjectsParticipants did not enter washout and Period 2
FG0150 subjectsParticipants did not enter washout and Period 2
FG0160 subjectsParticipants did not enter washout and Period 2
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period2, Escalation Phase1, Upto Day 84
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects1 Par directly entered into Period 2, Esc 1
FG0102 subjects1 Par cont in P2 Esc 1 insteadP1 Esc 5, was not withdrawn
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period2, Escalation Phase2, Upto Day 91
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period2, Escalation Phase3, Upto Day 98
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period2, Escalation Phase4, Upto Day 105
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period2,Escalation Phase5,Upto Day 112
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0081 subjects
FG0092 subjects
FG0102 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm AB - FF Followed by FP
Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
BG001
AC - FF Followed by BUD
Participants will receive PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants will receive PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period will be of 25-42 days
BG002
Arm AD - FF Followed by ELLIPTA Placebo
Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
BG003
Arm BA - FP Followed by FF
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
BG004
Arm BC - FP Followed by BUD
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
BG005
Arm BE - FP Followed by DISKUS Placebo
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
BG006
Arm CA - BUD Followed by FF
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
BG007
Arm CB - BUD Followed by FP
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
BG008
Arm CE - BUD Followed by DISKUS Placebo
Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
BG009
Arm DA - ELLIPTA Placebo Followed by FF
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
BG010
EB - DISKUS Placebo Followed by FP
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
BG011
Arm DC - ELLIPTA Placebo Followed by BUD
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
BG012
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
BG013
Fluticasone Propionate (FP)
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
BG014
Budesonide (BUD)
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
BG015
ELLIPTA
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
BG016
DISKUS
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0013
BG0022
BG0032
BG0043
BG0053
BG0062
BG0072
BG0082
BG0093
BG0102
BG0112
BG0127
BG0137
BG0146
BG0153
BG0163
BG01754
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<=18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ASIAN - CENTRAL/SOUTH ASIAN HERITAGE
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis
The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.
Pharmacodymanic (PD) population. Participants who were randomized and received at least one dose of trial medication and also have at least one post dose PD measurement. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
95% Confidence Interval
Milligrams per milliliter
12 hours post last dose on Day 7
ID
Title
Description
OG000
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG001
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG002
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG004
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG005
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG006
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG007
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.
PD population. Only those participants with data available for each dose escalation phase were analyzed.
Posted
Mean
95% Confidence Interval
nanomoles per liter
Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
ID
Title
Description
OG000
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG001
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG002
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
Primary
Theraputic Index of FF
Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
PD population. Only those participants with data available at the specified time points were analyzed.
Posted
Number
Ratio
12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
ID
Title
Description
OG000
Fluticasone Propionate (FP)
Participants received FF ELLIPTA 25 mcg, 100 mcg, 200 mcg, 400 mcg, 800 mcg for 7 days.
Units
Counts
Participants
OG000
Primary
Theraputic Index of FP
Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
PD population. Only those participants with data available at the specified time points were analyzed.
Posted
Number
Ratio
12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
ID
Title
Description
OG000
Fluticasone Propionate (FP)
Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
Units
Counts
Participants
OG000
Primary
Theraputic Index of BUD
Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
PD population. Only those participants with data available at the specified time points were analyzed.
Posted
Number
Ratio
12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
ID
Title
Description
OG000
Budesonide (BUD)
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.
All Subjects Population was consisted of all participants who were randomized and who received at least one dose of trial medication.
Posted
Count of Participants
Participants
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
All subjects Population.
Posted
Mean
Standard Error
Liters per minute
Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2,3,4,5,6,7 PM in period 1
ID
Title
Description
OG000
FF 25 mcg
Participants received FF ELLIPTA 25 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2,3,4,5,6,7 PM in period 2
ID
Title
Description
OG000
FF 25 mcg
Participants received FF ELLIPTA 25 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 8,9,10,11,12,13,14 PM in period 1
ID
Title
Description
OG000
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed
Posted
Mean
Standard Error
Liters per minute
Day 8,9,10,11,12,13,14 PM in period 2
ID
Title
Description
OG000
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 15,16,17,18,19,20,21 PM in period 1
ID
Title
Description
OG000
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2
ID
Title
Description
OG000
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Days 22,23,24,25,26,27,28 PM in period 1
ID
Title
Description
OG000
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Days 22,23,24,25,26,27,28 PM in period 2
ID
Title
Description
OG000
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Days 29,30,31,32,33,34,35 PM in period 1
ID
Title
Description
OG000
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Day 29,30,31,32,33,34,35 PM in period 2
ID
Title
Description
OG000
FF 400 mcg
Participants received FF ELLIPTA 400 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2,3,4,5,6,7 PM in period 1
ID
Title
Description
OG000
FP 50 mcg
Participants received FP ELLIPTA 50 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2,3,4,5,6,7 AM and PM in period 2
ID
Title
Description
OG000
FP 50 mcg
Participants received FP ELLIPTA 50 mcg 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Days 8,9,1,0,11,12,13,14 AM and PM in period 1
ID
Title
Description
OG000
FP 200 mcg
Participants received FP DISKSU 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 8,9,1,0,11,12,13,14 AM and PM in period 2
ID
Title
Description
OG000
FP 200 mcg
Participants received FP DISKSUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1
ID
Title
Description
OG000
FP 500 mcg
Participants received FP DISKSUS 250 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2
ID
Title
Description
OG000
FP 500 mcg
Participants received FP DISKUS 250 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1
ID
Title
Description
OG000
FP 1000 mcg
Participants received FP DISKSUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2
ID
Title
Description
OG000
FP 1000 mcg
Participants received FP DISKSUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1
ID
Title
Description
OG000
FP 2000 mcg
Participants received FP DISKSU 500 mcg 2 puffs AM and 2 puffs PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2
ID
Title
Description
OG000
FP 2000 mcg
Participants received FP DISKSU 500 mcg 2 puffs AM and 2 puffs PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2 to 6 AM and PM, Day 7 PM in period 1
ID
Title
Description
OG000
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 2,3,4,5,6,7 PM in period 2
ID
Title
Description
OG000
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 8 PM, Day 9 to 14 AM and PM in period 1
ID
Title
Description
OG000
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Day 8 PM, Day 9 to 14 AM and PM in period 2
ID
Title
Description
OG000
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1
ID
Title
Description
OG000
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2
ID
Title
Description
OG000
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1
ID
Title
Description
OG000
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Error
Liters per minute
Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2
ID
Title
Description
OG000
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1
ID
Title
Description
OG000
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Liters per minute
Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2
ID
Title
Description
OG000
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
All subjects Population.
Posted
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
Secondary
Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate
Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
All subjects Population
Posted
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
OG004
Secondary
Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate
Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
All subjects Population.
Posted
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
OG004
Secondary
Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature
Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
All subjects Population.
Posted
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
OG004
Secondary
Number of Participants With Abnormal Physical Examination
Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.
All subjects Population.
Posted
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
OG004
Secondary
Number of Participants With Clinically Significant Abnormal Hematology Parameters
Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.
All subjects Population.
Posted
Count of Participants
Participants
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
Secondary
Number of Participants With Clinically Significant Abnormal Chemistry Parameters
Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.
All subjects Population.
Posted
Count of Participants
Participants
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
Secondary
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters
Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.
All subjects Population.
Posted
Count of Participants
Participants
Up to Week 18
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
OG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
Secondary
Forced Expiratory Volume in 1 Second (FEV 1) in Period 1
FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.
All Subjects Population.
Posted
Mean
Standard Error
Liter
Day 1 (pre-dose) in Period 1
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
OG002
Fluticasone Propionate (FP)
Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
Secondary
Forced Expiratory Volume in 1 Second (FEV 1) in Period 2
FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
All Subjects Population.
Posted
Mean
Standard Error
Liter
Day 1 (pre-dose) in Period 2
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
OG002
Fluticasone Propionate (FP)
Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
OG003
Secondary
Forced Vital Capacity (FVC) in Period 1
FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
All Subjects Population.
Posted
Mean
Standard Error
Liter
Day 1 (pre-dose) in Period 1
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
OG002
Fluticasone Propionate (FP)
Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
OG003
Budesonide (BUD)
Secondary
Forced Vital Capacity (FVC) in Period 2
FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
All Subjects Population.
Posted
Mean
Standard Error
Liter
Day 1 (pre-dose) in Period 2
ID
Title
Description
OG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
OG001
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
OG002
Fluticasone Propionate (FP)
Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
OG003
Budesonide (BUD)
Time Frame
Serious adverse events and non-serious adverse events were collected up to 18 weeks.
Description
All subjects Population was used to collect the adverse events.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
0
17
0
17
10
17
EG001
FF 25 mcg
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
0
20
0
20
6
20
EG002
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
0
19
0
19
8
19
EG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
0
19
0
19
7
19
EG004
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
0
18
0
18
6
18
EG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
0
18
0
18
7
18
EG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
0
21
0
21
10
21
EG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
0
20
0
20
4
20
EG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
0
20
0
20
4
20
EG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
0
18
0
18
8
18
EG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
0
17
0
17
6
17
EG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
0
18
0
18
6
18
EG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
0
18
0
18
8
18
EG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
0
18
0
18
5
18
EG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
0
18
0
18
6
18
EG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
0
18
0
18
3
18
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0008 events4 affected17 at risk
EG0015 events5 affected20 at risk
EG0023 events3 affected19 at risk
EG0031 events1 affected19 at risk
EG0042 events2 affected18 at risk
EG0051 events1 affected18 at risk
EG0062 events2 affected21 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected18 at risk
EG0102 events2 affected17 at risk
EG0112 events2 affected18 at risk
EG0122 events2 affected18 at risk
EG0133 events3 affected18 at risk
EG0143 events3 affected18 at risk
EG0153 events2 affected18 at risk
Seasonal allergy
Immune system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected19 at risk
EG003
Chest discomfort
General disorders
MedDRA (21.1)
Systematic Assessment
EG0004 events2 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected19 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0003 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site bruise
General disorders
MedDRA (21.1)
Systematic Assessment
EG0002 events2 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected19 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0002 events2 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site related reaction
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected19 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected19 at risk
EG003
Eye swelling
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Feeling jittery
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Genital discomfort
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected19 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Keloid scar
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Phlebitis
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Saliva altered
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Sinonasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Syncope
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Tooth repair
Surgical and medical procedures
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA (21.1)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected19 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG010
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG011
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG012
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG014
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
18
OG00417
OG00520
OG00620
OG00718
OG00816
OG00917
OG01018
OG01118
OG01218
OG01318
OG01417
145.97
(85.02 to 250.59)
OG004167.26(95.36 to 293.37)
OG00515.19(10.80 to 21.36)
OG00620.47(13.94 to 30.07)
OG00731.39(18.88 to 52.19)
OG00848.67(27.30 to 86.78)
OG00976.35(43.21 to 134.91)
OG01016.00(11.41 to 22.44)
OG01123.91(15.08 to 37.90)
OG01234.62(19.28 to 62.16)
OG01354.33(28.40 to 103.93)
OG01484.17(45.48 to 155.79)
3 parameter Emax model
14.44
2-Sided
95
8.21
25.40
Emax-Maximum Dose response
Other
OG000
OG002
OG003
OG004
3 parameter Emax model
48.52
2-Sided
95
18.21
129.32
ED50-Dose at which 50% of the maximum dose response reached (mcg)
Other
OG005
OG006
OG007
OG008
OG009
3 parameter Emax model
13.50
2-Sided
95
9.39
19.39
FP E0-Response of Placebo participants
Other
OG005
OG006
OG007
OG008
OG009
3 parameter Emax model
14.44
2-Sided
95
8.21
25.40
FP Emax-Maximum Dose response
Other
OG005
OG006
OG007
OG008
OG009
3 parameter Emax model
1081.27
2-Sided
95
448.00
2609.66
FP ED50-Dose at which 50% of the maximum dose response reached (mcg)
Other
OG010
OG011
OG012
OG013
OG014
3 parameter Emax model
13.50
2-Sided
95
9.39
19.39
BUD E0-Response of Placebo participants
Other
OG010
OG011
OG012
OG013
OG014
3 parameter Emax model
14.44
2-Sided
95
8.21
25.40
BUD Emax-Maximum Dose response
Other
OG010
OG011
OG012
OG013
OG014
3 parameter Emax model
1467.36
2-Sided
95
546.51
3939.84
BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)
Other
OG003
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG004
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG005
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG006
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG007
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG010
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG011
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG012
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG014
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG00019
OG00119
OG00218
OG00318
OG00418
OG00520
OG00619
OG00718
OG00816
OG00916
OG01016
OG01116
OG01218
OG01318
OG01417
Title
Denominators
Categories
Title
Measurements
OG000172.73(159.88 to 186.62)
OG001163.03(151.01 to 176.02)
OG002150.95(139.48 to 163.37)
OG003129.40(117.82 to 142.12)
OG00495.09(82.26 to 109.93)
OG005173.04(160.15 to 186.97)
OG006164.22(152.11 to 177.29)
OG007147.89(136.59 to 160.13)
OG008124.21(112.88 to 136.68)
OG00987.62(75.37 to 101.85)
OG010169.87(157.23 to 183.52)
OG011152.50(141.26 to 164.63)
OG012132.06(122.05 to 142.90)
OG01399.05(90.24 to 108.72)
OG01455.71(48.26 to 64.31)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Exponential power-law model
176.09
2-Sided
95
162.87
190.38
FF E0-Response of Placebo participants
Other
OG000
OG001
OG002
OG003
OG004
exponential power-law model
899.99
2-Sided
95
698.36
1101.62
FF ED50 Dose at which 50% of the maximum dose response reached
Other
OG005
OG006
OG007
OG008
OG009
exponential power-law model
176.09
2-Sided
95
162.87
190.38
FP E0-Response of Placebo participants
Other
OG005
OG006
OG007
OG008
OG009
exponential power-law model
1986.05
2-Sided
95
1574.70
2397.39
FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)
Other
OG010
OG011
OG012
OG013
exponential power-law model
176.09
2-Sided
95
162.87
190.38
BUD E0 - Response of Placebo participants
Other
OG010
OG011
OG012
OG013
OG014
exponential power-law model
1927.42
2-Sided
95
1698.47
2156.37
BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)
Other
51
Title
Denominators
Categories
Title
Measurements
OG0001.49
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Emax Model
289.73
2-Sided
95
224.82
354.64
ED20 Cortisol Suppression 0-24 Hours Weighted Mean
Other
OG000
Emax Model
194.09
2-Sided
95
72.82
517.28
ED80 for AMP PC20
Other
51
Title
Denominators
Categories
Title
Measurements
OG0000.15
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Emax Model
639.36
2-Sided
95
506.94
771.79
ED20 for Cortisol Suppression 0-24 Hours Weighted Mean
Other
OG000
Emax Model
4325.07
2-Sided
95
1792.02
10438.64
ED80 for AMP PC20
Other
51
Title
Denominators
Categories
Title
Measurements
OG0000.11
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Emax Model
620.49
2-Sided
95
546.79
694.20
ED20 for Cortisol Suppression 0-24 Hours Weighted Mean
Other
OG000
Emax Model
5869.45
2-Sided
95
2186.03
15759.35
ED80 for AMP PC20
Other
OG003
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
OG004
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG00017
OG00120
OG00219
OG00319
OG00418
OG00518
OG00621
OG00720
OG00820
OG00918
OG01017
OG01118
OG01218
OG01318
OG01418
OG01518
Title
Denominators
Categories
Any AEs
Title
Measurements
OG00010
OG0016
OG0028
OG0037
OG0046
OG0057
OG00610
OG0074
OG0084
OG0098
OG0106
OG0116
OG0128
OG0135
OG0146
OG0153
Any SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
12
Title
Denominators
Categories
Day 2, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000522.5± 25.4
Day 3, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000517.5± 27.0
Day 4, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000514.2± 27.8
Day 5,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000521.7± 24.2
Day 6, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000522.5± 29.1
Day 7, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000539.2± 32.3
Day 8, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000530.8± 27.8
Day 9, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000576.0± 37.5
Day 9, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000531.3± 27.9
Day 10, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000572.0± 34.4
Day 10, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000535.0± 22.0
Day 11, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000578.0± 35.9
Day 11, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000533.8± 29.0
Day 12, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000578.0± 37.2
Day 12 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000527.5± 26.7
Day 13, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000580.0± 37.4
Day 13, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000540.8± 25.1
Day 14, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000572.0± 34.7
Day 14, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000543.3± 26.4
Day 15, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000530.8± 26.0
Day 16, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000588.0± 36.1
Day 16,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000528.3± 24.4
Day 17, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000586.0± 31.7
Day 17,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000521.7± 32.5
Day 18, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000586.0± 35.0
Day 18,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000540.0± 26.9
Day 19, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000568.0± 38.3
Day 19,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000535.8± 29.3
Day 20, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000596.0± 37.5
Day 20,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000544.2± 28.2
Day 21, AM, n=5
ParticipantsOG0005
Title
Measurements
OG000580.0± 31.4
Day 21,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000534.2± 32.6
Day 22,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000544.5± 29.0
Day 23, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000577.5± 37.9
Day 23,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000530.0± 27.4
Day 24, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000567.5± 39.4
Day 24,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000526.4± 26.5
Day 25, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000585.0± 39.2
Day 25,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000530.9± 29.6
Day 26, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000582.5± 40.0
Day 26,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000518.2± 30.0
Day 27, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000587.5± 40.0
Day 27,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000539.1± 29.3
Day 28, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000587.5± 43.0
Day 28,PM, n=10
ParticipantsOG00010
Title
Measurements
OG000547.0± 30.4
Day 29,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000547.3± 28.2
Day 30, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000567.5± 38.1
Day 30,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000527.3± 26.6
Day 31, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000562.5± 33.2
Day 31,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000537.3± 26.5
Day 32, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000582.5± 40.2
Day 32,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000537.3± 26.2
Day 33, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000597.5± 40.0
Day 33,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000528.2± 30.5
Day 34, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000580.0± 39.3
Day 34,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000531.4± 31.9
Day 35, AM, n=4
ParticipantsOG0004
Title
Measurements
OG000565.0± 38.8
Day 35,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000501.8± 26.1
4
Title
Denominators
Categories
Day 2, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000422.5± 28.9
Day 3, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000415.0± 27.2
Day 4, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000398.8± 26.6
Day 5,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000407.5± 37.5
Day 6, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000411.3± 29.0
Day 7, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000410.0± 36.7
Day 8, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000415.0± 36.1
Day 9, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000430.0± 80.0
Day 9, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000411.3± 45.4
Day 10, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000425.0± 65.0
Day 10, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000403.8± 37.1
Day 11, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000410.0± 60.0
Day 11, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000395.0± 29.0
Day 12, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000400.0± 50.0
Day 12, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000398.8± 28.6
Day 13, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000415.0± 95.0
Day 13, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000425.0± 35.2
Day 14, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000425.0± 65.0
Day 14, PM, n=3
ParticipantsOG0003
Title
Measurements
OG000420.0± 40.4
Day 15, PM, n=4
ParticipantsOG0004
Title
Measurements
OG000416.3± 37.0
Day 16, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000405.0± 75.0
Day 16,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000405.0± 32.0
Day 17, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000390.0± 70.0
Day 17,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000405.0± 28.9
Day 18, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000450.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 18,PM,n=3
ParticipantsOG0003
Title
Measurements
OG000423.3± 34.8
Day 19, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000415.0± 65.0
Day 19,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000402.5± 30.1
Day 20, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000402.5± 57.5
Day 20,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000398.8± 36.3
Day 21, AM, n=2
ParticipantsOG0002
Title
Measurements
OG000400.0± 60.0
Day 21,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000395.0± 38.6
Day 22,PM, n=4
ParticipantsOG0004
Title
Measurements
OG000397.5± 34.9
Day 23, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000480.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 23,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000415.0± 39.0
Day 24, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000460.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 24,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000423.3± 38.4
Day 25, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000460.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 25,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000416.7± 33.8
Day 26, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000450.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 26,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000418.3± 36.7
Day 27, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000460.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 27,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000433.3± 49.7
Day 28, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000460.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 28,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000430.0± 49.3
Day 29,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000380.0± 75.5
Day 30, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000460.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 30,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000388.3± 78.0
Day 31, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000480.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 31,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000390.0± 85.0
Day 32, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000500.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 32,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000370.0± 73.7
Day 33, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000470.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 33,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000370.0± 70.9
Day 34, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000460.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 34,PM, n=3
ParticipantsOG0003
Title
Measurements
OG000390.0± 83.2
Day 35, AM, n=1
ParticipantsOG0001
Title
Measurements
OG000480.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 35,PM, n=2
ParticipantsOG0002
Title
Measurements
OG000345.0± 105.0
14
Title
Denominators
Categories
Day 2, PM, n=14
ParticipantsOG00014
Title
Measurements
OG000479.6± 30.9
Day 3, PM, n=14
ParticipantsOG00014
Title
Measurements
OG000475.7± 32.9
Day 4, PM, n=14
ParticipantsOG00014
Title
Measurements
OG000473.0± 31.1
Day 5,PM, n=14
ParticipantsOG00014
Title
Measurements
OG000476.1± 26.6
Day 6, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000503.1± 24.6
Day 7, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000502.3± 28.1
6
Title
Denominators
Categories
Day 2, PM, n=5
ParticipantsOG0005
Title
Measurements
OG000572.0± 48.9
Day 3, PM, n=5
ParticipantsOG0005
Title
Measurements
OG000570.0± 54.5
Day 4, PM, n=5
ParticipantsOG0005
Title
Measurements
OG000568.0± 55.0
Day 5,PM, n=5
ParticipantsOG0005
Title
Measurements
OG000573.0± 54.9
Day 6, PM, n=6
ParticipantsOG0006
Title
Measurements
OG000550.8± 52.2
Day 7, PM, n=6
ParticipantsOG0006
Title
Measurements
OG000560.0± 45.3
13
Title
Denominators
Categories
Day 8, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000497.3± 24.9
Day 9, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000500.4± 28.2
Day 10, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000491.2± 31.0
Day 11, PM, n=12
ParticipantsOG00012
Title
Measurements
OG000507.5± 30.9
Day 12, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000500.2± 30.2
Day 13, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000515.4± 29.7
Day 14, PM, n=13
ParticipantsOG00013
Title
Measurements
OG000505.8± 28.7
6
Title
Denominators
Categories
Day 8, PM
Title
Measurements
OG000540.0± 43.8
Day 9, PM
Title
Measurements
OG000567.5± 42.6
Day 10, PM
Title
Measurements
OG000556.7± 43.4
Day 11, PM
Title
Measurements
OG000561.7± 44.6
Day 12, PM
Title
Measurements
OG000573.3± 50.0
Day 13, PM
Title
Measurements
OG000563.3± 53.0
Day 14, PM
Title
Measurements
OG000555.8± 46.9
13
Title
Denominators
Categories
Day 15,PM, n=13
ParticipantsOG00013
Title
Measurements
OG000500.8± 30.8
Day 16,PM, n=13
ParticipantsOG00013
Title
Measurements
OG000500.0± 28.7
Day 17,PM, n=13
ParticipantsOG00013
Title
Measurements
OG000506.2± 29.8
Day 18,PM, n=13
ParticipantsOG00013
Title
Measurements
OG000514.2± 31.6
Day 19,PM, n=13
ParticipantsOG00013
Title
Measurements
OG000505.4± 29.0
Day 20,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000505.8± 30.8
Day 21,PM, n=12
ParticipantsOG00012
Title
Measurements
OG000485.0± 28.2
6
Title
Denominators
Categories
Day 15,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000575.0± 52.9
Day 16,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000575.0± 48.1
Day 17,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000564.2± 46.6
Day 18,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000573.3± 56.6
Day 19,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000556.7± 53.4
Day 20,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000571.7± 50.0
Day 21,AM, n=1
ParticipantsOG0001
Title
Measurements
OG000670.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 21,PM, n=6
ParticipantsOG0006
Title
Measurements
OG000560.0± 38.3
12
Title
Denominators
Categories
Day 22 PM
Title
Measurements
OG000496.7± 30.5
Day 23 PM
Title
Measurements
OG000481.0± 25.6
Day 24 PM
Title
Measurements
OG000484.6± 25.2
Day 25 PM
Title
Measurements
OG000488.3± 26.2
Day 26 PM
Title
Measurements
OG000496.7± 28.8
Day 27 PM
Title
Measurements
OG000508.8± 28.9
Day 28 PM
Title
Measurements
OG000486.7± 23.7
6
Title
Denominators
Categories
Day 22 PM
Title
Measurements
OG000556.7± 46.9
Day 23 PM
Title
Measurements
OG000566.7± 47.8
Day 24 PM
Title
Measurements
OG000571.7± 50.8
Day 25 PM
Title
Measurements
OG000568.3± 52.7
Day 26 PM
Title
Measurements
OG000565.0± 43.0
Day 27 PM
Title
Measurements
OG000540.0± 43.3
Day 28 PM
Title
Measurements
OG000541.7± 41.2
12
Title
Denominators
Categories
Day 29 PM
Title
Measurements
OG000496.7± 27.0
Day 30 PM
Title
Measurements
OG000487.1± 25.9
Day 31 PM
Title
Measurements
OG000488.3± 24.1
Day 32 PM
Title
Measurements
OG000481.3± 25.8
Day 33 PM
Title
Measurements
OG000481.5± 24.9
Day 34 PM
Title
Measurements
OG000487.5± 28.7
Day 35 PM
Title
Measurements
OG000471.0± 26.6
6
Title
Denominators
Categories
Day 29 PM
Title
Measurements
OG000576.7± 44.9
Day 30 PM
Title
Measurements
OG000560.0± 48.7
Day 31 PM
Title
Measurements
OG000553.3± 45.0
Day 32 PM
Title
Measurements
OG000565.0± 50.7
Day 33 PM
Title
Measurements
OG000580.0± 48.9
Day 34 PM
Title
Measurements
OG000568.3± 42.3
Day 35 PM
Title
Measurements
OG000556.7± 44.9
15
Title
Denominators
Categories
Day 2 PM, n=15
ParticipantsOG00015
Title
Measurements
OG000529.3± 28.0
Day 3 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000533.6± 30.3
Day 4 PM, n=15
ParticipantsOG00015
Title
Measurements
OG000532.3± 30.8
Day 5 PM, n=15
ParticipantsOG00015
Title
Measurements
OG000524.0± 29.9
Day 6 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000519.3± 26.4
Day 7 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000502.9± 35.1
6
Title
Denominators
Categories
Day 2 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 2 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000490.0± 40.6
Day 3 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 3 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000486.7± 42.3
Day 4 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000590.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 4 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000491.7± 42.6
Day 5 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 5 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000491.7± 44.6
Day 6 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 6 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000490.0± 44.3
Day 7 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 7 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000466.0± 48.9
14
Title
Denominators
Categories
Day 8 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000540.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 8 PM, n=13
ParticipantsOG00013
Title
Measurements
OG000532.7± 33.2
Day 9 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000500.9± 38.3
Day 9 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000517.9± 26.8
Day 10 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000521.0± 39.0
Day 10 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000513.2± 28.5
Day 11 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000476.4± 35.4
Day 11 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000512.1± 30.0
Day 12 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000506.8± 38.0
Day 12 PM, n=13
ParticipantsOG00013
Title
Measurements
OG000528.8± 34.3
Day 13 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000500.0± 38.2
Day 13 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000514.6± 31.1
Day 14 AM, n=13
ParticipantsOG00013
Title
Measurements
OG000496.2± 31.7
Day14 PM, n=13
ParticipantsOG00013
Title
Measurements
OG000522.7± 32.9
6
Title
Denominators
Categories
Day 8 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000610.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 8 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000500.0± 43.2
Day 9 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000506.0± 39.5
Day 9 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000488.3± 43.7
Day 10 AM, n=4
ParticipantsOG0004
Title
Measurements
OG000515.0± 44.0
Day 10 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000490.0± 47.1
Day 11 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000504.0± 36.1
Day 11 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000485.0± 42.6
Day 12 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000508.0± 41.4
Day 12 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000493.3± 42.8
Day 13 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000500.0± 40.1
Day 13 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000495.0± 45.8
Day 14 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000438.0± 46.6
Day 14 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000495.8± 48.8
14
Title
Denominators
Categories
Day 15 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000527.5± 29.7
Day 16 AM, n=13
ParticipantsOG00013
Title
Measurements
OG000503.8± 31.9
Day 16 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000520.4± 29.5
Day 17 AM, n=13
ParticipantsOG00013
Title
Measurements
OG000510.0± 30.3
Day 17 PM, n=14
ParticipantsOG00014
Title
Measurements
OG000508.6± 31.2
Day 18 AM, n=12
ParticipantsOG00012
Title
Measurements
OG000497.5± 34.7
Day 18 PM, n=13
ParticipantsOG00013
Title
Measurements
OG000505.8± 28.5
Day 19 AM, n=12
ParticipantsOG00012
Title
Measurements
OG000505.8± 35.2
Day 19 PM, n=13
ParticipantsOG00013
Title
Measurements
OG000506.9± 29.5
Day 20 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000518.2± 35.9
Day 20 PM, n=13
ParticipantsOG00013
Title
Measurements
OG000517.3± 30.4
Day 21 AM, n=13
ParticipantsOG00013
Title
Measurements
OG000501.9± 32.1
Day 21 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000493.6± 30.0
Day 22 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000520.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 22 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000540.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 23 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 23 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000550.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 24 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 24 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000540.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 25 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000510.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 25 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000500.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 26 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000520.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 26 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000550.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 27 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 27 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000580.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 28 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 28 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000500.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
6
Title
Denominators
Categories
Day 15 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000486.7± 43.8
Day 16 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000476.7± 43.8
Day 16 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000503.3± 46.8
Day 17 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000493.3± 44.0
Day 17 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000500.0± 45.9
Day 18 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000476.7± 39.9
Day 18 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000495.0± 42.8
Day 19 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000454.0± 44.3
Day 19 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000500.0± 45.1
Day 20 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000524.0± 43.6
Day 20 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000501.7± 50.6
Day 21 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000490.0± 44.2
Day 21 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000496.7± 48.4
11
Title
Denominators
Categories
Day 22 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000523.2± 30.5
Day 23 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000511.8± 36.4
Day 23 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000516.4± 38.4
Day 24 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000521.8± 38.0
Day 24 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000520.9± 37.1
Day 25 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000489.5± 35.1
Day 25 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000521.0± 42.7
Day 26 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000502.7± 37.0
Day 26 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000517.3± 35.7
Day 27 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000493.6± 33.0
Day 27 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000523.6± 37.7
Day 28 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000500.0± 40.6
Day 28,PM, n=11
ParticipantsOG00011
Title
Measurements
OG000516.4± 33.9
Day 29 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 30 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000520.0± NANA indicates standard error could not be calculated as only one participant was analyzed..
Day 30 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 31 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000510.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 31 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 32 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000520.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 32 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000550.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 33 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000530.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 33 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000540.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 34 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000510.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 34 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000520.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 35 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000540.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 35 PM, n=1
ParticipantsOG0001
Title
Measurements
OG000550.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
6
Title
Denominators
Categories
Day 22 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000493.3± 42.8
Day 23 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000480.0± 43.4
Day 23 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000506.7± 43.5
Day 24 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000481.7± 39.4
Day 24 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000505.0± 45.3
Day 25 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000491.7± 43.9
Day 25 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000510.0± 51.7
Day 26 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000485.0± 45.3
Day 26 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000501.7± 49.9
Day 27 AM, n=6
ParticipantsOG0006
Title
Measurements
OG000475.0± 42.3
Day 27 PM, n=6
ParticipantsOG0006
Title
Measurements
OG000490.0± 43.2
Day 28 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000452.0± 47.7
Day 28,PM, n=5
ParticipantsOG0005
Title
Measurements
OG000476.0± 56.8
10
Title
Denominators
Categories
Day 29 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000520.5± 36.5
Day 30 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000505.0± 39.0
Day 30 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000520.0± 40.9
Day 31 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000507.0± 37.0
Day 31 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000521.0± 41.7
Day 32 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000500.0± 39.6
Day 32 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000524.0± 41.9
Day 33 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000511.0± 40.7
Day 33 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000511.5± 43.2
Day 34 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000519.0± 38.9
Day 34 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000517.0± 38.9
Day 35 AM, n=9
ParticipantsOG0009
Title
Measurements
OG000514.4± 40.4
Day 35 PM, n=9
ParticipantsOG0009
Title
Measurements
OG000543.9± 44.1
6
Title
Denominators
Categories
Day 29 PM
Title
Measurements
OG000506.7± 45.8
Day 30 AM
Title
Measurements
OG000493.3± 45.0
Day 30 PM
Title
Measurements
OG000496.7± 46.8
Day 31 AM
Title
Measurements
OG000486.7± 48.0
Day 31 PM
Title
Measurements
OG000485.0± 41.6
Day 32 AM
Title
Measurements
OG000488.3± 44.7
Day 32 PM
Title
Measurements
OG000513.3± 52.6
Day 33 AM
Title
Measurements
OG000495.0± 45.3
Day 33 PM
Title
Measurements
OG000498.3± 44.1
Day 34 AM
Title
Measurements
OG000481.7± 46.0
Day 34 PM
Title
Measurements
OG000498.3± 47.7
Day 35 AM
Title
Measurements
OG000483.3± 44.2
Day 35 PM
Title
Measurements
OG000493.3± 46.3
12
Title
Denominators
Categories
Day 2 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 2 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000512.9± 33.4
Day 3 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 3 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000517.1± 31.2
Day 4 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000625.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 4 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000524.2± 32.9
Day 5 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 5 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000520.8± 32.3
Day 6 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000600.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 6 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000523.3± 33.5
Day 7 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000527.5± 33.4
4
Title
Denominators
Categories
Day 2 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000557.5± 28.3
Day 3 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000547.5± 60.1
Day 4 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000545.0± 27.2
Day 5 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000552.5± 46.0
Day 6 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000577.5± 26.5
Day 7 PM, n=3
ParticipantsOG0003
Title
Measurements
OG000603.3± 32.8
12
Title
Denominators
Categories
Day 8 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000521.7± 31.5
Day 9 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000473.0± 30.5
Day 9 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000515.4± 34.3
Day 10 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000470.0± 33.9
Day 10 PM, n=12
ParticipantsOG00012
Title
Measurements
OG000512.9± 32.8
Day 11 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000466.7± 36.0
Day 11 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000492.5± 35.2
Day 12 AM, n=9
ParticipantsOG0009
Title
Measurements
OG000451.1± 28.6
Day 12 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000509.5± 33.7
Day 13 AM, n=9
ParticipantsOG0009
Title
Measurements
OG000457.8± 33.9
Day 13 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000506.8± 33.1
Day 14 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000480.5± 30.3
Day 14 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000496.4± 32.1
5
Title
Denominators
Categories
Day 8 PM
Title
Measurements
OG000560.0± 43.3
Day 9 AM
Title
Measurements
OG000552.0± 40.1
Day 9 PM
Title
Measurements
OG000560.0± 34.7
Day 10 AM
Title
Measurements
OG000552.0± 34.9
Day 10 PM
Title
Measurements
OG000556.0± 30.7
Day 11 AM
Title
Measurements
OG000562.0± 26.7
Day 11 PM
Title
Measurements
OG000574.0± 30.4
Day 12 AM
Title
Measurements
OG000568.0± 29.3
Day 12 PM
Title
Measurements
OG000578.0± 44.2
Day 13 AM
Title
Measurements
OG000562.0± 28.1
Day 13 PM
Title
Measurements
OG000588.0± 37.6
Day 14 AM
Title
Measurements
OG000586.0± 22.2
Day 14 PM
Title
Measurements
OG000590.0± 44.6
11
Title
Denominators
Categories
Day 15 AM, n=1
ParticipantsOG0001
Title
Measurements
OG000610.0± NANA indicates standard error could not be calculated as only one participant was analyzed.
Day 15 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000515.5± 30.1
Day 16 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000494.5± 31.9
Day 16 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000507.3± 34.9
Day 17 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000484.1± 33.4
Day 17 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000505.0± 34.8
Day 18 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000492.7± 33.4
Day 18 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000503.2± 36.4
Day 19 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000483.2± 29.7
Day 19 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000487.7± 38.0
Day 20 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000483.6± 31.7
Day 20 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000517.7± 33.9
Day 21 AM, n=11
ParticipantsOG00011
Title
Measurements
OG000490.5± 27.2
Day 21 PM, n=11
ParticipantsOG00011
Title
Measurements
OG000509.1± 32.9
5
Title
Denominators
Categories
Day 15 PM
Title
Measurements
OG000578.0± 32.0
Day 16 AM
Title
Measurements
OG000568.0± 37.6
Day 16 PM
Title
Measurements
OG000572.0± 45.3
Day 17 AM
Title
Measurements
OG000572.0± 27.8
Day 17 PM
Title
Measurements
OG000558.0± 46.0
Day 18 AM
Title
Measurements
OG000558.0± 45.8
Day 18 PM
Title
Measurements
OG000568.0± 53.1
Day 19 AM
Title
Measurements
OG000572.0± 46.4
Day 19 PM
Title
Measurements
OG000584.0± 47.3
Day 20 AM
Title
Measurements
OG000590.0± 37.6
Day 20 PM
Title
Measurements
OG000590.0± 37.6
Day 21 AM
Title
Measurements
OG000574.0± 23.5
Day 21 PM
Title
Measurements
OG000606.0± 38.0
11
Title
Denominators
Categories
Day 22 PM
Title
Measurements
OG000506.4± 33.9
Day 23 AM
Title
Measurements
OG000496.4± 29.8
Day 23 PM
Title
Measurements
OG000512.7± 32.3
Day 24 AM
Title
Measurements
OG000498.2± 34.8
Day 24 PM
Title
Measurements
OG000510.5± 34.9
Day 25 AM
Title
Measurements
OG000500.5± 32.8
Day 25 PM
Title
Measurements
OG000514.1± 33.2
Day 26 AM
Title
Measurements
OG000499.1± 31.3
Day 26 PM
Title
Measurements
OG000512.3± 35.2
Day 27 AM
Title
Measurements
OG000491.4± 31.0
Day 27 PM
Title
Measurements
OG000497.7± 37.3
Day 28 AM
Title
Measurements
OG000476.8± 27.9
Day 28 PM
Title
Measurements
OG000526.8± 33.9
5
Title
Denominators
Categories
Day 22 PM
Title
Measurements
OG000594.0± 47.8
Day 23 AM
Title
Measurements
OG000578.0± 40.0
Day 23 PM
Title
Measurements
OG000586.0± 46.4
Day 24 AM
Title
Measurements
OG000556.0± 37.8
Day 24 PM
Title
Measurements
OG000556.0± 45.2
Day 25 AM
Title
Measurements
OG000564.0± 50.6
Day 25 PM
Title
Measurements
OG000594.0± 45.4
Day 26 AM
Title
Measurements
OG000584.0± 45.6
Day 26 PM
Title
Measurements
OG000568.0± 51.1
Day 27 AM
Title
Measurements
OG000568.0± 52.1
Day 27 PM
Title
Measurements
OG000584.0± 35.3
Day 28 AM
Title
Measurements
OG000574.0± 30.1
Day 28 PM
Title
Measurements
OG000630.0± 46.0
10
Title
Denominators
Categories
Day 29 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000493.0± 31.9
Day 30 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000482.0± 33.5
Day 30 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000502.0± 33.3
Day 31 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000482.0± 34.0
Day 31 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000496.0± 32.4
Day 32 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000482.0± 30.1
Day 32 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000488.0± 33.0
Day 33 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000483.0± 29.1
Day 33 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000490.0± 35.0
Day 34 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000489.0± 31.3
Day 34 PM, n=9
ParticipantsOG0009
Title
Measurements
OG000522.2± 33.4
Day 35 AM, n=10
ParticipantsOG00010
Title
Measurements
OG000474.0± 33.8
Day 35 PM, n=10
ParticipantsOG00010
Title
Measurements
OG000488.0± 30.6
5
Title
Denominators
Categories
Day 29 PM, n=5
ParticipantsOG0005
Title
Measurements
OG000596.0± 43.8
Day 30 AM, n=5
ParticipantsOG0005
Title
Measurements
OG000604.0± 22.7
Day 30 PM, n=5
ParticipantsOG0005
Title
Measurements
OG000586.0± 41.5
Day 31 AM, n=4
ParticipantsOG0004
Title
Measurements
OG000562.5± 33.5
Day 31 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000547.5± 43.8
Day 32 AM, n=4
ParticipantsOG0004
Title
Measurements
OG000592.5± 38.6
Day 32 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000587.5± 18.8
Day 33 AM, n=4
ParticipantsOG0004
Title
Measurements
OG000567.5± 30.3
Day 33 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000565.0± 42.9
Day 34 AM, n=4
ParticipantsOG0004
Title
Measurements
OG000585.0± 38.4
Day 34 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000583.8± 29.6
Day 35 AM, n=4
ParticipantsOG0004
Title
Measurements
OG000577.5± 35.6
Day 35 PM, n=4
ParticipantsOG0004
Title
Measurements
OG000597.5± 38.6
OG004
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG004
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG00017
OG00120
OG00219
OG00319
OG00418
OG00518
OG00621
OG00720
OG00820
OG00918
OG01017
OG01118
OG01218
OG01318
OG01418
OG01518
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG004
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG00017
OG00120
OG00219
OG00319
OG00418
OG00518
OG00621
OG00720
OG00820
OG00918
OG01017
OG01118
OG01218
OG01318
OG01418
OG01518
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG004
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
OG005
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
OG006
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
OG007
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG008
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG009
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG010
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG011
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
OG012
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG013
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
OG014
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
OG015
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
Units
Counts
Participants
OG00017
OG00120
OG00219
OG00319
OG00418
OG00518
OG00621
OG00720
OG00820
OG00918
OG01017
OG01118
OG01218
OG01318
OG01418
OG01518
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG003
Budesonide.
Participants received Participants received BUD Turbuhaler 100 mcg, 400 mcg, 800 mcg, 1600 mcg, 3200 mcg as total daily dose for 7 days.
Units
Counts
Participants
OG00012
OG00114
OG00215
OG00312
Title
Denominators
Categories
Title
Measurements
OG0003.18± 0.151
OG0013.02± 0.166
OG0023.50± 0.269
OG0033.29± 0.274
Budesonide (BUD)
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
Title
Denominators
Categories
Title
Measurements
OG0002.67± 0.482
OG0013.44± 0.431
OG0022.68± 0.278
OG0033.46± 0.257
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
Units
Counts
Participants
OG00012
OG00114
OG00215
OG00312
Title
Denominators
Categories
Title
Measurements
OG0004.55± 0.221
OG0014.36± 0.222
OG0025.15± 0.287
OG0034.70± 0.406
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.