Efficacy and Safety Study of Fluticasone Furoate (FF)/GW6... | NCT01054885 | Trialant
NCT01054885
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jan 24, 2018Actual
Enrollment
1,226Actual
Phase
Phase 3
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
FF Inhalation Powder
FF/GW642444 Inhalation Powder
GW642444 Inhalation Powder
Placebo
Countries
United States
Argentina
Czechia
Germany
Japan
Poland
Romania
Russia
Ukraine
Protocol Section
Identification Module
NCT ID
NCT01054885
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
112207
Secondary IDs
Not provided
Brief Title
Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared With Placebo in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jan 2018
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
Oct 19, 2009
Primary Completion Date
Feb 1, 2011Actual
Completion Date
Feb 8, 2011Actual
First Submitted Date
Jan 14, 2010
First Submission Date that Met QC Criteria
Jan 21, 2010
First Posted Date
Jan 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 12, 2013
Results First Submitted that Met QC Criteria
Jun 12, 2013
Results First Posted Date
Aug 15, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 16, 2012
Certification/Extension First Submitted that Passed QC Review
Feb 16, 2012
Certification/Extension First Posted Date
Feb 20, 2012Estimated
Last Update Submitted Date
Jan 18, 2018
Last Update Posted Date
Jan 24, 2018Actual
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
Not provided
Is FDA Regulated Device
Not provided
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
The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
Detailed Description
Not provided
Conditions Module
Conditions
Pulmonary Disease, Chronic Obstructive
Keywords
COPD
Chronic Obstructive Pulmonary Disease
Efficacy
FEV1
Safety
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,226Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Fluticasone Furoate Inhalation Powder
Experimental
Inhaled Corticosteroid (ICS)
Drug: FF Inhalation Powder
FF Inhalation Pwdr
Experimental
Inhaled Corticosteroid (ICS)
Drug: FF Inhalation Powder
Fluticasone Furoate/GW642444 Inhalation Powder
Experimental
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Drug: FF/GW642444 Inhalation Powder
FF/GW642444 Inhalation Pwdr
Experimental
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Drug: FF/GW642444 Inhalation Powder
GW642444 Inhalation Powder
Experimental
Long Acting Beta Agonist(LABA)
Drug: GW642444 Inhalation Powder
Placebo
Placebo Comparator
Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FF Inhalation Powder
Drug
Inhaled Corticosteroid (ICS)
FF Inhalation Pwdr
Fluticasone Furoate Inhalation Powder
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Baseline (BL) to Day 168
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Baseline to Day 169
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168
Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Type of subject: outpatient
Informed consent: Subjects must give their signed and dated written informed consent to participate.
Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of:
Non-child bearing potential OR
Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
Age: ≥40 years of age at Screening (Visit 1)
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
FEV1/FVC ratio of ≤0.70 and
FEV1 ≤70% of predicted normal values
Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Asthma: Subjects with a current diagnosis of asthma
α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medication or components of the inhalation powder
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at each study visit
Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary.
Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
Prior use of study medication/other investigational drugs
Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
Yang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70059. doi: 10.1002/psp4.70059. Epub 2025 Jun 19.
See Also Links
Label
URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Eligible participants (par.) completed a 2-week single-blind (placebo) Run-in Period (RIP) to assess Baseline rescue use, symptoms, disease stability. Par. were then randomized to a 24-week Treatment Period. A total of 1909 par. were screened, 1577 entered the RIP, of whom 1226 were randomized, 1224 received at least one dose of study medication.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Run-in
Participants received placebo once daily (OD) in the morning for 2 weeks.
FG001
Placebo
Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
Periods
Title
Milestones
Reasons Not Completed
2-week, Single-blind Run-In Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Placebo
FF/GW642444 Inhalation Powder
Drug
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
FF/GW642444 Inhalation Pwdr
Fluticasone Furoate/GW642444 Inhalation Powder
GW642444 Inhalation Powder
Drug
Long Acting Beta Agonist(LABA)
GW642444 Inhalation Powder
Placebo
Drug
Placebo
Placebo
Baseline to Day 168
Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.
Baseline and Day 1
Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.
Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
FG002
FF 100 µg OD
Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
FG003
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
FG004
VI 25 µg OD
Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
FG005
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
FG006
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
FG0001577 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0001226 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000351 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Did Not Meet Continuation Criteria
FG000246 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Physician Decision
FG0006 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00023 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0007 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Closed/Terminated
FG00068 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
24-week, Double-blind Treatment Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001205 subjects
FG002204 subjects
FG003203 subjects
FG004203 subjects
FG005204 subjects
FG006205 subjects
COMPLETED
FG0000 subjects
FG001146 subjects
FG002155 subjects
FG003160 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00159 subjects
FG00249 subjects
FG00343 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG00118 subjects
FG00212 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo OD in the morning from the DPI for 24 weeks.
BG001
FF 100 µg OD
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
BG002
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
BG003
VI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
BG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
BG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000205
BG001204
BG002203
BG003203
BG004204
BG005205
BG0061224
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00061.9± 8.14
BG00161.8± 8.28
BG00261.8± 9.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00053
BG00154
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
African American/African Heritage (HER)
Title
Measurements
BG0000
BG0012
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
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis
Posted
Least Squares Mean
Standard Error
Liters
Baseline (BL) to Day 168
ID
Title
Description
OG000
Placebo
Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001
FF 100 µg OD
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
OG002
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
OG003
VI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
OG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
OG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Units
Counts
Participants
OG000147
OG001154
OG002162
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.012± 0.0189
OG0010.034± 0.0187
OG0020.029± 0.0185
OG003
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
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.085
Least squares mean difference
0.046
2-Sided
95
-0.006
0.098
Superiority or Other
OG000
OG002
Mixed Models Analysis
Primary
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis
Posted
Least Squares Mean
Standard Error
Liters
Baseline to Day 169
ID
Title
Description
OG000
Placebo
Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001
FF 100 µg OD
Secondary
Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168
Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.
Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis
Posted
Least Squares Mean
Standard Error
Scores on a scale
Baseline to Day 168
ID
Title
Description
OG000
Placebo
Participants received placebo OD in the morning from the DPI for 24 weeks.
Secondary
Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.
Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.
Posted
Least Squares Mean
Standard Error
Liters
Baseline and Day 1
ID
Title
Description
OG000
Placebo
Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001
FF 100 µg OD
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
Secondary
Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.
Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.
Posted
Median
Full Range
Minutes
Baseline and Day 1
ID
Title
Description
OG000
Placebo
Participants received placebo OD in the morning from the DPI for 24 weeks.
OG001
FF 100 µg OD
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
OG002
FF 200 µg OD
Time Frame
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24).
Description
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
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 placebo OD in the morning from the DPI for 24 weeks.
10
205
39
205
EG001
FF 100 µg OD
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
6
204
32
204
EG002
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
10
203
46
203
EG003
VI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
16
203
43
203
EG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
12
204
36
204
EG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
15
205
40
205
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0005 affected205 at risk
EG0010 affected204 at risk
EG0022 affected203 at risk
EG0035 affected203 at risk
EG004
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0022 affected203 at risk
EG003
Infective exacerbation of chronic obstructive airway disease
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Accidental poisoning
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0022 affected203 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Thrombotic stroke
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Device occlusion
General disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0021 affected203 at risk
EG003
Metabolic disorder
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected204 at risk
EG0020 affected203 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Venous insufficiency
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected204 at risk
EG0020 affected203 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG00017 affected205 at risk
EG00114 affected204 at risk
EG00220 affected203 at risk
EG00319 affected203 at risk
EG00413 affected204 at risk
EG00513 affected205 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected205 at risk
EG0013 affected204 at risk
EG0025 affected203 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected205 at risk
EG0015 affected204 at risk
EG0025 affected203 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0003 affected205 at risk
EG0010 affected204 at risk
EG0027 affected203 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG00015 affected205 at risk
EG00113 affected204 at risk
EG00211 affected203 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0003 affected205 at risk
EG0013 affected204 at risk
EG0027 affected203 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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D029424
Pulmonary Disease, Chronic Obstructive
Ancestor Terms
ID
Term
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
161 subjects
FG005144 subjects
FG006158 subjects
42 subjects
FG00560 subjects
FG00647 subjects
15 subjects
FG00415 subjects
FG00517 subjects
FG00619 subjects
Lack of Efficacy-No Sub-Reason
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy-Sub-Reason Exacerbation
FG0000 subjects
FG00112 subjects
FG0022 subjects
FG0035 subjects
FG00411 subjects
FG0057 subjects
FG0067 subjects
Protocol Violation
FG0000 subjects
FG0017 subjects
FG0027 subjects
FG0032 subjects
FG0043 subjects
FG0058 subjects
FG0064 subjects
Protocol Defined Stopping Criteria
FG0000 subjects
FG0017 subjects
FG00212 subjects
FG0037 subjects
FG0047 subjects
FG00515 subjects
FG00612 subjects
Study Closed/ Terminated
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
Physician Decision
FG0000 subjects
FG0014 subjects
FG0021 subjects
FG0036 subjects
FG0043 subjects
FG0051 subjects
FG0061 subjects
Withdrawal by Subject
FG0000 subjects
FG0018 subjects
FG0029 subjects
FG0037 subjects
FG0043 subjects
FG0059 subjects
FG0062 subjects
61.2
± 8.62
BG00461.9± 8.79
BG00561.1± 8.67
BG00661.6± 8.58
52
BG00352
BG00460
BG00568
BG006339
Male
BG000152
BG001150
BG002151
BG003151
BG004144
BG005137
BG006885
5
BG0033
BG0044
BG0052
BG00616
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0042
BG0050
BG0063
Japanese/East Asian HER/South East Asian HER
Title
Measurements
BG0008
BG0015
BG00214
BG0034
BG0048
BG00511
BG00650
White
Title
Measurements
BG000197
BG001197
BG002183
BG003196
BG004190
BG005192
BG0061155
160
OG004146
OG005158
0.173
± 0.0184
OG0040.202± 0.0190
OG0050.197± 0.0184
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.123
Least squares mean difference
0.041
2-Sided
95
-0.011
0.093
Superiority or Other
OG000
OG003
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Least squares mean difference
0.185
2-Sided
95
0.133
0.237
Superiority or Other
OG000
OG004
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Nominal p-value
Least squares mean difference
0.214
2-Sided
95
0.161
0.266
Superiority or Other
OG000
OG005
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Least squares mean difference
0.209
2-Sided
95
0.157
0.261
Superiority or Other
OG001
OG004
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Nominal p-value
Least squares mean difference
0.168
2-Sided
95
0.116
0.220
Superiority or Other
OG002
OG005
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Least squares mean difference
0.168
2-Sided
95
0.117
0.219
Superiority or Other
OG003
OG004
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.274
Least squares mean difference
0.029
2-Sided
95
-0.023
0.081
Superiority or Other
OG003
OG005
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.357
Least squares mean difference
0.024
2-Sided
95
-0.027
0.075
Superiority or Other
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
OG002
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
OG003
VI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
OG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
OG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Units
Counts
Participants
OG000142
OG001148
OG002155
OG003150
OG004137
OG005153
Title
Denominators
Categories
Title
Measurements
OG0000.004± 0.0189
OG0010.048± 0.0187
OG0020.012± 0.0185
OG0030.103± 0.0185
OG0040.148± 0.0191
OG0050.135± 0.0185
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
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.095
Least squares mean difference
0.044
2-Sided
95
-0.008
0.097
Superiority or Other
OG000
OG002
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.756
Least squares mean difference
0.008
2-Sided
95
-0.044
0.060
Superiority or Other
OG000
OG003
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Least squares mean difference
0.100
2-Sided
95
0.048
0.151
Superiority or Other
OG000
OG004
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Nominal p-value
Least squares mean difference
0.144
2-Sided
95
0.091
0.197
Superiority or Other
OG000
OG005
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Least squares mean difference
0.131
2-Sided
95
0.080
0.183
Superiority or Other
OG001
OG004
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Nominal p-value
Least squares mean difference
0.100
2-Sided
95
0.047
0.152
Superiority or Other
OG002
OG005
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
<0.001
Nominal p-value
Least squares mean difference
0.123
2-Sided
95
0.072
0.174
Superiority or Other
OG003
OG004
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.093
Least squares mean difference
0.045
2-Sided
95
-0.008
0.097
Superiority or Other
OG003
OG005
Mixed Models Analysis
Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
0.224
Least squares mean difference
0.032
2-Sided
95
-0.019
0.083
Superiority or Other
OG001
FF 100 µg OD
Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
OG002
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
OG003
VI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
OG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
OG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Units
Counts
Participants
OG000146
OG001154
OG002161
OG003161
OG004146
OG005156
Title
Denominators
Categories
Title
Measurements
OG0000.21± 0.077
OG0010.10± 0.076
OG0020.21± 0.075
OG0030.28± 0.075
OG0040.45± 0.078
OG0050.31± 0.075
OG002
FF 200 µg OD
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
OG003
FVI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
OG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
OG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Units
Counts
Participants
OG000204
OG001203
OG002202
OG003201
OG004203
OG005205
Title
Denominators
Categories
Title
Measurements
OG0000.120± 0.0108
OG0010.144± 0.0109
OG0020.127± 0.0109
OG0030.267± 0.0109
OG0040.272± 0.0109
OG0050.261± 0.0108
Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
OG003
VI 25 µg OD
Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
OG004
FF/VI 100/25 µg OD
Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
OG005
FF/VI 200/25 µg OD
Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Units
Counts
Participants
OG000204
OG001203
OG002202
OG003201
OG004203
OG005205
Title
Denominators
Categories
Title
Measurements
OG000NA(5 to 240)\> 50% of participants were censored; therefore, the median could not be calculated.