CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 704 enrolled
Drug / intervention
QAW039 +1 moredrug
Likely dose
QAW039 once dailyAI-extracted
Key inclusion· 7
  • ✓Asthma diagnosis for ≥6 months per GINA 2016
  • ✓Treated with medium-dose ICS, high-dose ICS, low-dose ICS + LABA, low-dose ICS + LTRA, or medium-dose ICS + LABA for ≥3 months, stable dose ≥4 weeks
  • ✓FEV1 ≤85% for age ≥18 years; FEV1 ≤90% for age 12 to <18 years
  • ✓Daytime asthma symptoms (score ≥1/day) on ≥4 of last 7 days of run-in
Key exclusion· 5
  • ✕Investigational drugs within 5 half-lives or 30 days (whichever longer)
  • ✕QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female)
  • ✕Pregnancy or nursing/lactation
  • ✕Serious co-morbidities

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03226392
NCT03226392Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jul 21, 2017·Updated Jan 13, 2026

In Brief

A Phase 3 clinical trial evaluating QAW039 and Placebo for Asthma. Completed, enrolled 704 participants across 142 sites in 18 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
CountriesBrazil, Bulgaria, Canada, Colombia, Germany, Hungary, India, Israel, Italy, Peru, Puerto Rico, Russia, South Korea, Spain, Sweden, Tunisia, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartOct 31, 2017
Primary CompletionJul 5, 2019
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.9 years ago

Interventions

QAW039drug

QAW039 once daily

Placebodrug

Placebo once daily