At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 675 enrolled
Drug / intervention
QAW039 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
In Brief
A Phase 3 clinical trial evaluating QAW039 and Placebo for Asthma. Completed, enrolled 675 participants across 110 sites in 10 countries.
Detailed Summary
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Germany, Hungary, Mexico, Philippines, Saudi Arabia, Slovakia, South Africa, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartNov 2017
Primary CompletionJul 2019
Study CompletionJul 2019
TodayJul 2026
First PostedJul 12, 2017
Enrollment StartNov 1, 2017
Primary CompletionJul 2, 2019
Study CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.0 years ago
Interventions
QAW039drug
QAW039 once daily
Placebodrug
Placebo once daily