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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,020
Combination inhaled corticosteroid and long-acting beta2-agonist
Inhaled corticosteroid
Number of Participants With 1 or More Severe Asthma Exacerbations
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.
Time frame: Baseline to Follow-up (up to 76 weeks of treatment)
Number of Severe Asthma Exacerbations
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.
Time frame: Baseline to Follow-up (up to 76 weeks of treatment)
Change From Baseline in Evening Pre-dose Trough FEV1 at 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.
Time frame: Baseline and Week 36
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Oxford, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Bell Gardens, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
...and 173 more locations