Efficacy, Safety, and Pharmacokinetics of QAW039

Phase 2

Completed

• Conditions: Persistent Asthma
• Interventions: Drug: Placebo to QAW039 capsules once daily for 28 days; Drug: Fluticasone propionate inhaler twice daily for 28 days; Drug: QAW039 capsules once daily for 28 days

• Registration Number: NCT01253603
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-08
• Disposition First Submitted: 2013-10-29
• Disposition First Submitted QC: 2013-10-29
• Disposition First Posted: 2013-11-21
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo to QAW039 capsules once daily for 28 days	Placebo to QAW039 capsules once daily for 28 days
3	Fluticasone propionate inhaler twice daily for 28 days	Fluticasone propionate inhaler twice daily for 28 days
1	QAW039 capsules once daily for 28 days	QAW039 capsules once daily for 28 days

Primary Outcome Measures

Name	Time	Method
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.	28 days

Secondary Outcome Measures

Name	Time	Method
To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.	28 days

Trial Locations

Locations (2)

Novatis Investigative Site; 🇺🇸 Upland, Pennsylvania, United States

Novartis Investigative Site; 🇷🇴 Bucharest, Romania