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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03226392

Run by

Novartis Pharmaceuticals

People needed

704

Starts

2017-10-31

Expected to finish

2019-08-01

Last updated by the study team

2026-01-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Newport Beach, California, United States
• Novartis Investigative Site — Rolling Hills Estates, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Jose, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Lafayette, Colorado, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami Gardens, Florida, United States
• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Paducah, Kentucky, United States
• Novartis Investigative Site — Columbia, Maryland, United States
• Novartis Investigative Site — White Marsh, Maryland, United States
• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

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