drugset / Trial / NCT03215758

Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

NCT03215758

Phase 3 Completed 675 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-11-01
Primary completion
2019-07-02
Completion
2019-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator fevipiprant Small molecule

Indications