asthma
Conditions
Interventions
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Inadequately controlled asthma (ACQ-6 score *1.5) at Visit 2. * A best pre-bronchodilator morning (AM) FEV1 *30% and
Exclusion criteria
Exclusion criteria: * Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject*s asthma status or the subject*s ability to participate in the study. * Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days (1) or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. (1) For subjects on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. * Changes in asthma medication (excluding run-in medication and salbutamol inhalation aerosol provided at Visit 1). * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough FEV1 at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate/severe asthma exacerbations. FEV1 3h post dose (week 24), Mean change from baseline in ACQ-7, SGRQ, total score at Week 24. Mean change from baseline in Evaluating Respiratory Symptoms (E-RS) total score over the first 24 weeks of the treatment period. Adverse effects. | — |
Countries
Austria, Canada, Germany, Italy, Japan, Korea (the Republic of), Netherlands, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States of America
Outcome results
None listed