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The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate/GW642444 | Experimental | Combination inhaled corticosteroid and long-acting beta2-agonist |
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| Fluticasone Furoate | Experimental | Inhaled corticosteroid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate/GW642444 Inhalation Powder | Drug | Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | An AE is defined as 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as 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, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE. | From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chiba | 277-0863 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. | |
| 27881132 |
| 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. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113989 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Following screening (Visit1) and a 2-week Run-in Period during which participants continued to use their respective asthma therapy at a fixed dose. Participants who met continuation criteria at the end of Run-in Period (Visit 2) were allocated to a 52-Week Treatment Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | FF/GW642444 100/25 µg | Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg ) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period. |
| FG001 | FF/GW642444 200/25 µg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluticasone Furoate Inhalation Powder | Drug | Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks |
|
| Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD. | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
| Change From Baseline in the 24-hour Urinary Cortisol Excretion | Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. | Baseline (Week 0), Week 24, and Week 52/WD |
| Change From Baseline in Blood Pressure | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Week 0), Week 12, Week 24, and Week 52/WD |
| Change From Baseline in Heart Rate (HR) | Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Week 0), Week 12, Week 24, and Week 52/WD |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS. | Week 12, Week 24, and Week 52/WD |
| Number of Participants With Severe Asthma Exacerbation During the Study Treatment | A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations. | Baseline up to Week 52 |
| Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. | Baseline up to Week 52 |
| Change From Baseline in Asthma Symptom Score During the Study Treatment | The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping. | Baseline up to Week 52 |
| Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment | Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline. | Baseline up to Week 52 |
| Change From Baseline in the Percentage of Rescue-free 24-hour Periods | The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline. | Baseline up to Week 52 |
| Number of Rescue Medication Inhalations | Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening). | Baseline up to Week 52 |
| Fukuoka |
| 802-0083 |
| Japan |
| GSK Investigational Site | Fukuoka | 816-0813 | Japan |
| GSK Investigational Site | Gifu | 501-6062 | Japan |
| GSK Investigational Site | Gunma | 373-0021 | Japan |
| GSK Investigational Site | Hiroshima | 730-0844 | Japan |
| GSK Investigational Site | Hiroshima | 732-0062 | Japan |
| GSK Investigational Site | Hiroshima | 739-0402 | Japan |
| GSK Investigational Site | Hyōgo | 665-0827 | Japan |
| GSK Investigational Site | Hyōgo | 670-0046 | Japan |
| GSK Investigational Site | Hyōgo | 672-8064 | Japan |
| GSK Investigational Site | Ibaraki | 302-0022 | Japan |
| GSK Investigational Site | Kanagawa | 231-8682 | Japan |
| GSK Investigational Site | Kanagawa | 253-0041 | Japan |
| GSK Investigational Site | Kyoto | 601-1495 | Japan |
| GSK Investigational Site | Kyoto | 615-8087 | Japan |
| GSK Investigational Site | Miyagi | 983-0824 | Japan |
| GSK Investigational Site | Miyagi | 983-8520 | Japan |
| GSK Investigational Site | Nagano | 390-0303 | Japan |
| GSK Investigational Site | Nagano | 390-8510 | Japan |
| GSK Investigational Site | Okayama | 700-0862 | Japan |
| GSK Investigational Site | Okayama | 701-0304 | Japan |
| GSK Investigational Site | Okayama | 714-0081 | Japan |
| GSK Investigational Site | Osaka | 545-8586 | Japan |
| GSK Investigational Site | Osaka | 569-1192 | Japan |
| GSK Investigational Site | Osaka | 589-0022 | Japan |
| GSK Investigational Site | Tokyo | 105-0004 | Japan |
| GSK Investigational Site | Tokyo | 134-0083 | Japan |
| GSK Investigational Site | Tokyo | 185-0014 | Japan |
| GSK Investigational Site | Toyama | 937-0066 | Japan |
| Derived |
| O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113989 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113989 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113989 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113989 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113989 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113989 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period. |
| FG002 | FF 100 µg | Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FF/GW642444 100/25 µg | Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period. |
| BG001 | FF/GW642444 200/25 µg | Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period. |
| BG002 | FF 100 µg | Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | An AE is defined as 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as 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, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE. | Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period | Posted | Number | Participants | From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) |
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| Secondary | Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | Percentage | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | 10^9 per liter (Gi/L) | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | Proportions of I | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | 10^12 per liter (Ti/L) | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | g/L | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | International unit per liter (IU/L) | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | Micromoles per Liter (µmol/L) | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | Millimoles per Liter (mmol/L) | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | pH | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD | Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Mean | Standard Deviation | ratio of urine density to water density | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD | Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD. | ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Number | Participants | Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
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| Secondary | Change From Baseline in the 24-hour Urinary Cortisol Excretion | Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. | Urine cortisol (UC) Population: all participants in the ITT Population from whom urine specimens were collected and who were considered not to have any confounding factors that might affect the analysis of the results of the specimens. Only those participants with post-Baseline data available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles (nmol)/24 hours | Baseline (Week 0), Week 24, and Week 52/WD |
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| Secondary | Change From Baseline in Blood Pressure | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline (Week 0), Week 12, Week 24, and Week 52/WD |
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| Secondary | Change From Baseline in Heart Rate (HR) | Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Beats/Minute | Baseline (Week 0), Week 12, Week 24, and Week 52/WD |
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| Secondary | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS. | ITT Population. . Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X". | Posted | Number | Participants | Week 12, Week 24, and Week 52/WD |
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| Secondary | Number of Participants With Severe Asthma Exacerbation During the Study Treatment | A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations. | ITT Population | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment | Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. | ITT Population | Posted | Mean | Standard Deviation | Litres per Minute (L/min) | Baseline up to Week 52 |
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| Secondary | Change From Baseline in Asthma Symptom Score During the Study Treatment | The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping. | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline up to Week 52 |
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| Secondary | Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment | Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline. | ITT Population | Posted | Mean | Standard Deviation | Percentage of symptom-free days | Baseline up to Week 52 |
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| Secondary | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline. | ITT Population | Posted | Mean | Standard Deviation | Percentage of rescue free 24-hour period | Baseline up to Week 52 |
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| Secondary | Number of Rescue Medication Inhalations | Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening). | ITT Population. The number of participants analyzed depends on the number of participants remaining in the indaicated time period. | Posted | Mean | Standard Deviation | Number of inhalations | Baseline up to Week 52 |
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On-treatment non-serious adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose in each treatment period (up to 52 weeks), are reported. SAEs, defined as those events o
SAEs and non-serious AEs were collected in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FF/GW642444 100/25 µg | Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period. | 4 | 60 | 52 | 60 | ||
| EG001 | FF/GW642444 200/25 µg | Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period. | 7 | 93 | 77 | 93 | ||
| EG002 | FF 100 µg | Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. | 1 | 90 | 72 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
Not provided
Not provided
Not provided
| Male |
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Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
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| OG002 | FF 100 µg | Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. |
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| OG002 | FF 100 µg | Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. |
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| OG002 |
| FF 100 µg |
Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. |
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| OG002 | FF 100 µg | Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period. |
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