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

NCT03226392

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Asthma

Interventions: QAW039, Placebo

Countries: United States, Brazil, Bulgaria, Canada, Colombia, Germany, Hungary, India

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Locations (142)

Andalusia, Alabama, United States
Birmingham, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Newport Beach, California, United States
Rolling Hills Estates, California, United States
San Diego, California, United States
San Diego, California, United States
San Jose, California, United States
Stockton, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lafayette, Colorado, United States
Miami, Florida, United States
Miami Gardens, Florida, United States
Tallahassee, Florida, United States
Winter Park, Florida, United States
Paducah, Kentucky, United States
Columbia, Maryland, United States
White Marsh, Maryland, United States
North Dartmouth, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Saint Charles, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Warrensburg, Missouri, United States
Omaha, Nebraska, United States
Brooklyn, New York, United States
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