Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

Official Title
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A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids

Conditions
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Asthma

Intervention / Treatment
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* Drug: Vilanterol
* Drug: Salmeterol Inhalation Powder
* Drug: Placebo Inhalation Powder NDPI
* Drug: Placebo Inhalation Powder Diskus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient at least 12 years of age Both genders; females of childbearing potential must be willing to use birth control method Clinical diagnosis of asthma for ≥12 weeks Best pre-bronchodilator FEV1 of 40%-90% predicted Reversibility of FEV1 of at least 12% and 200mls Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits Exclusion Criteria: History of life-threatening asthma Respiratory infection within last 4 weeks leading to change in asthma management Asthma exacerbation within last 3 months Concurrent respiratory disease or other disease that would confound study participation or affect subject safety Allergies to study drugs, study drugs' excipients, or medications related to study drugs Taking another investigational medication or medication prohibited for use during the study. Previous participation in a vilanterol (GW642444) study

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilanterol<br>Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks | Drug: Vilanterol<br>* Vilanterol inhalation powder inhaled orally once daily for 12 weeks<br>Drug: Placebo Inhalation Powder Diskus<br>* Placebo inhalation powder inhaled orally twice daily for 12 weeks<br>|
| Active Comparator: Salmeterol<br>Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks | Drug: Salmeterol Inhalation Powder<br>* Salmeterol inhalation powder inhaled orally twice daily for 12 weeks<br>Drug: Placebo Inhalation Powder NDPI<br>* Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler<br>|
| Placebo Comparator: Placebo<br>Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks | Drug: Placebo Inhalation Powder NDPI<br>* Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler<br>Drug: Placebo Inhalation Powder Diskus<br>* Placebo inhalation powder inhaled orally twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 | FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period | The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 | 
| Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period | Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 | 
| Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points | FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point. | Baseline and Week 12 | 
| Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 | 
| Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment. | Baseline and Weeks 1-12 | 
| Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours) | The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored. | Day 1 and Week 12 | 
| Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12 | At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often. | Week 4 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma