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This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice daily [BD]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.
SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate/Vilanterol 100/25 mcg | Experimental | FF/VI 100/25 mcg by inhalation OD (PM) via ELLIPTA plus placebo by inhalation BD (AM and PM) via ACCUHALER/DISKUS for 24 weeks. |
|
| Fluticasone Propionate/Salmeterol 250/50 mcg | Experimental | FP/Salmeterol 250/50 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks. |
|
| Fluticasone Propionate 250 mcg | Experimental | FP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler | Drug | FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population | FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication. | Baseline and Week 24 |
| Change From Baseline in PM FEV1 Using Per Protocol (PP) Population | FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Percentage of Rescue-free 24-hour Periods | The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. |
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Huntington Beach | California | 92647 | United States | ||
| 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. | |
| 28961020 |
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A total of 3162 adult and adolescent participants with asthma were screened, out of which 516 were screen-failures, 1124 were run-in failures, 1522 participants were randomized, and 1504 subjects received at least one dose of study medication to be included in the Intent-to-Treat (ITT) Population.
Eligible participants at screening and run-in visits entered a 24 Week treatment period and were randomized to receive either Fluticasone furoate/Vilanterol (FF/VI) 100/25 micrograms (mcg) or Fluticasone propionate/salmeterol (FP/S) 250/50mcg or only FP 250mcg followed by a follow-up phase. The total duration for study participation was 30 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | FF/VI 100/25 mcg Once Daily | Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
| FG001 | FP/S 250/50 mcg Twice Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo inhalation powders via ELLIPTA inhaler | Drug | Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device. |
|
| Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler | Drug | FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation. |
|
| Placebo inhalation powder via ACCUHALER/DISKUS inhaler | Drug | Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device. |
|
| Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler | Drug | FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation. |
|
| Baseline and Weeks 1-24 |
| Change From Baseline in the Percentage of Symptom-free 24-hour Periods | Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | Baseline and Weeks 1-24 |
| Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) | PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | Baseline and Weeks 1-24 |
| Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20 | The ACT was a five-item questionnaire developed as a measure of participant's asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group. | Week 24 |
| Change From Baseline in PM PEF | PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | Baseline and Weeks 1-24 |
| Riverside |
| California |
| 92506 |
| United States |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | United States |
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| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70378 | Germany |
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| GSK Investigational Site | Munich | Bavaria | 80339 | Germany |
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| GSK Investigational Site | Peine | Lower Saxony | 31224 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45355 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | Germany |
| GSK Investigational Site | Warendorf | North Rhine-Westphalia | 48231 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58452 | Germany |
| GSK Investigational Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| GSK Investigational Site | Delitzsch | Saxony | 04509 | Germany |
| GSK Investigational Site | Leipzg | Saxony | 04109 | Germany |
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| GSK Investigational Site | Leipzig | Saxony | 04275 | Germany |
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| GSK Investigational Site | Teuchern | Saxony-Anhalt | 6682 | Germany |
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| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23552 | Germany |
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| GSK Investigational Site | Berlin | 12203 | Germany |
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| GSK Investigational Site | Zapopan | Jalisco | 45030 | Mexico |
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| GSK Investigational Site | Irkutsk | 664043 | Russia |
| GSK Investigational Site | Kemerovo | 650000 | Russia |
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| GSK Investigational Site | Krasnodar | 350012 | Russia |
| GSK Investigational Site | Moscow | 115201 | Russia |
| GSK Investigational Site | Moscow | 115478 | Russia |
| GSK Investigational Site | Moscow | 123 182 | Russia |
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| GSK Investigational Site | Saint Petesburg | 195030 | Russia |
| GSK Investigational Site | Saratov | 410028 | Russia |
| GSK Investigational Site | St'Petersburg | 197706 | Russia |
| GSK Investigational Site | Stavropol | 355017 | Russia |
| GSK Investigational Site | Tomsk | 634009 | Russia |
| GSK Investigational Site | Tomsk | 634033 | Russia |
| GSK Investigational Site | Ufa | 450071 | Russia |
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| GSK Investigational Site | Vladimir | 600023 | Russia |
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| GSK Investigational Site | Cheongju-si, Chungcheongbuk-do | 361-763 | South Korea |
| GSK Investigational Site | Incheon | 403-720 | South Korea |
| GSK Investigational Site | Seoul | 110-744 | South Korea |
| GSK Investigational Site | Seoul | 135-710 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | Suwon-si, Gyeonggi-do | 16499 | South Korea |
| GSK Investigational Site | Alicante | 03004 | Spain |
| GSK Investigational Site | Alzira/Valencia | 46600 | Spain |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08016 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Centelles (Barcelona) | 08540 | Spain |
| GSK Investigational Site | Madrid | 28009 | Spain |
| GSK Investigational Site | Pozuelo de Alarcón/Madrid | 28223 | Spain |
| GSK Investigational Site | Santander | 39008 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
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| Derived |
| Bernstein D, Andersen L, Forth R, Jacques L, Yates L. Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA. J Asthma. 2018 Sep;55(9):984-993. doi: 10.1080/02770903.2017.1386214. Epub 2018 Apr 13. |
Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
| FG002 | FP 250 mcg Twice Daily | Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FF/VI 100/25 mcg Once Daily | Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
| BG001 | FP/S 250/50 mcg Twice Daily | Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
| BG002 | FP 250 mcg Twice Daily | Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population | FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication. | ITT population | Posted | Least Squares Mean | Standard Error | Liter (L) | Baseline and Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in PM FEV1 Using Per Protocol (PP) Population | FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations. | PP Population | Posted | Least Squares Mean | Standard Error | L | Baseline and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Percentage of Rescue-free 24-hour Periods | The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | ITT Population | Posted | Least Squares Mean | Standard Error | Percentage of rescue-free 24-hr periods | Baseline and Weeks 1-24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Percentage of Symptom-free 24-hour Periods | Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | ITT Population | Posted | Least Squares Mean | Standard Error | Percentage of symptom-free 24 hour perio | Baseline and Weeks 1-24 |
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| Secondary | Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) | PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | ITT Population | Posted | Least Squares Mean | Standard Error | Liter per minute (L/min) | Baseline and Weeks 1-24 |
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| Secondary | Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20 | The ACT was a five-item questionnaire developed as a measure of participant's asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group. | ITT Population | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Change From Baseline in PM PEF | PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated. | ITT Population | Posted | Least Squares Mean | Standard Error | L/min | Baseline and Weeks 1-24 |
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On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up contact one week after completion of study medication (Up to Week 25).
AEs and SAEs were collected in ITT Population
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/VI 100/25 mcg Once Daily | Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. | 0 | 504 | 6 | 504 | 126 | 504 |
| EG001 | FP/S 250/50 mcg Twice Daily | Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. | 0 | 501 | 4 | 501 | 123 | 501 |
| EG002 | FP 250 mcg Twice Daily | Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. | 0 | 499 | 5 | 499 | 124 | 499 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Vocal cord leukoplakia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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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 |
| C550468 | vilanterol |
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
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| Asian - East Asian Heritage |
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| Asian- Japanese Heritage |
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| Asian- South East Asian Heritage |
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| Black/African American Heritage |
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| White- Arabic/ North African Heritage |
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| White- White/Caucasian/European Heritage |
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| White- Mixed White Race |
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| African American/ African and White Heritage |
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| American Indian/Alaskan Native and White Heritage |
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| Asian - East Asian and White Heritage |
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| Mixed Models Analysis |
| <0.001 |
| Least square mean change difference |
| 0.123 |
| 2-Sided |
| 95 |
| 0.093 |
| 0.153 |
| Other |
| Mixed Models Analysis | <0.001 | Least square mean change difference | 0.104 | 2-Sided | 95 | 0.074 | 0.134 | Other |
| OG002 | FP 250 mcg Twice Daily | Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
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| OG002 | FP 250 mcg Twice Daily | Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
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| OG002 | FP 250 mcg Twice Daily | Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms. |
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Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
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