Asthma Exacerbation Study
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|ClinicalTrials.gov Identifier: NCT01086384|
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : September 11, 2013
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Fluticasone Furoate/GW642444 Drug: Fluticasone furoate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2020 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma|
|Study Start Date :||February 22, 2010|
|Actual Primary Completion Date :||September 1, 2011|
|Actual Study Completion Date :||September 15, 2011|
|Experimental: Fluticasone furoate/GW642444||
Drug: Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
|Experimental: fluticasone furoate||
Drug: Fluticasone furoate
- Number of Participants With 1 or More Severe Asthma Exacerbations [ Time Frame: 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.
- Number of Severe Asthma Exacerbations [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086384
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|