Efficacy, Safety, and Pharmacokinetics of QAW039

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fluticasone; Indoleacetic Acids; Xhance

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.