Asthma Exacerbation Study

Phase 3

Completed

Brief Summary: This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

Recruitment & Eligibility

Inclusion Criteria

Clinical diagnosis of asthma
Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
FEV1 of fifty to ninety percent of predicted
Currently using inhaled corticosteroid therapy
History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

Exclusion Criteria

History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
Respiratory infection or oral candidiasis
- Uncontrolled disease or clinical abnormality
Allergies
Taking another investigational medication or prohibited medication

Arm && Interventions

Group	Intervention	Description
Fluticasone furoate/GW642444	Fluticasone Furoate/GW642444	-
fluticasone furoate	Fluticasone furoate	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With 1 or More Severe Asthma Exacerbations	Baseline to Follow-up (up to 76 weeks of treatment)	Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a 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. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second \[FEV1, maximum amount of air forcefully exhaled in one second\]), sex, age, and region.

Secondary Outcome Measures

Name	Time	Method
Number of Severe Asthma Exacerbations	Baseline to Follow-up (up to 76 weeks of treatment)	A severe asthma exacerbation is defined as a 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. A participant may have had one or more exacerbations.
Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36	Baseline and Week 36	Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.