Efficacy, Safety, and Pharmacokinetics of QAW039

Completed · Phase 2 · Has a placebo group

Conditions studied: Persistent Asthma

In brief

This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

Key facts

Study ID

NCT01253603

Run by

Novartis Pharmaceuticals

People needed

170

Starts

2010-11-01

Expected to finish

2011-09-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a medical history of mild to moderate persistent allergic asthma.
• Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m2.
• Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

You may not qualify if…

• Women of child-bearing potential.
• Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
• Patients with severe persistent asthma
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Encinitas, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Mission Viejo, 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 — Stockbridge, Georgia, United States
• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — Bellevue, Nebraska, United States
• Novartis Investigative Site — Berlin, New Jersey, United States
• Novartis Investigative Site — Skillman, New Jersey, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Medford, Oregon, United States
• Novatis Investigative Site — Upland, Pennsylvania, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Jambes, Belgium
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Wiesbaden, Germany
• Novartis Investigative Site — Bucharest, Romania

Full record on ClinicalTrials.gov

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