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Study was cancelled prior to enrolling any subjects
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate/Vilanterol | Active Comparator | Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks |
|
| Fluticasone Propionate | Active Comparator | Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate/Vilanterol Inhalation Powder | Drug | Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D001250 | Asthma, Exercise-Induced |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
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| Fluticasone Propionate Inhalation Powder | Drug | Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks |
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000092202 | Exercise-Induced Allergies |
| D001519 | Behavior |