A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.

Official Title
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A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice Daily in Asthmatic Adolescent and Adult Subjects With Exercise-Induced Bronchoconstriction

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fluticasone Furoate/Vilanterol Inhalation Powder
* Drug: Fluticasone Propionate Inhalation Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient male or female 12 to 50 years of age Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study Diagnosis of persistent asthma for at least 6 months Best pre-bronchodilator FEV1 of at least 70%. Current use of a low- to moderate-dose inhaled corticosteroid Ability to withhold albuterol 6 hours prior to visits. Physically able to perform exercise testing on a treadmill when albuterol has been withheld Exclusion Criteria: Intermittent asthma, seasonal asthma, or exercise-induced asthma only Symptomatic allergic rhinitis and/or thrush Abnormal, clinically significant electrocardigraph Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation Asthma exacerbation within 12 weeks of first visit Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study Allergy to study drugs or study drug excipients Concomitant medications that could interact with study medications or affect the course of asthma Tobacco use within last year and/or a 10 pack-years history Inability to comply with requirements of the study Affiliation with investigator's site (example: family member)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluticasone Furoate/Vilanterol<br>Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks | Drug: Fluticasone Furoate/Vilanterol Inhalation Powder<br>* Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks<br>|
| Active Comparator: Fluticasone Propionate<br>Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks | Drug: Fluticasone Propionate Inhalation Powder<br>* Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose |  | At the end of treatment Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose |  | At the end of treatment Week 4 | 
| Time required for recovery to within 5% of the pre-exercise baseline FEV1 from the time of the maximal percentage decrease from baseline following the challenge at 1 hour, 12 hours, and 23 hours post-dose |  | At the end of treatment Week 4 | 
| AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose |  | At the end of treatment Week 4 | 
| Evaluation of a categorical treatment response using the percentage of subjects who demonstrate a decrease from the pre-exercise baseline in FEV1 of 1) <10%, 2) 10 to <20%, and 3) =/>20%. |  | At the end of treatment Week 4 | 
| Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose. |  | At the end of treatment Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise-induced bronchospasm, Activity/Exercise induced bronchospasm, asthma