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

NCT03215758

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Asthma

Interventions: QAW039, Placebo

Countries: United States, Argentina, Germany, Hungary, Mexico, Philippines, Saudi Arabia, Slovakia

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 (110)

Flagstaff, Arizona, United States
Phoenix, Arizona, United States
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Mountain View, California, United States
Orange, California, United States
Roseville, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Tamarac, Florida, United States
Winter Park, Florida, United States
Albany, Georgia, United States
Dacula, Georgia, United States
Honolulu, Hawaii, United States
Lihue, Hawaii, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Columbia, Missouri, United States
Rolla, Missouri, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
La Vista, Nebraska, United States
Skillman, New Jersey, United States
Asheville, North Carolina, United States
Gastonia, North Carolina, United States
High Point, North Carolina, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
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