Number Type Age Range Length of study Compensation
CQAW039A2316/17 Adult/Adolescent Asthma 12 years and older approx. 12 weeks for time/travel
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
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.
- A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
- Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
- FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
- Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
- Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
- Demonstrated reversible airway obstruction.
- Asthma control questionnaire (ACQ) score ≥ 1.5.
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- A resting QTcF (Fridericia) ≥450 msec (male) or
≥460 msec (female).
- Pregnant or nursing (lactating) women.
- Serious co-morbidities.
- Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.