NCT01253603
Completed
Phase 2
A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma
Novartis Pharmaceuticals2 sites in 2 countries170 target enrollmentStarted: November 2010Last updated:
ConditionsPersistent Asthma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
Overview
Brief Summary
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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.
Arms & Interventions
1
Experimental
QAW039 capsules once daily for 28 days
Intervention: QAW039 capsules once daily for 28 days (Drug)
2
Experimental
Placebo to QAW039 capsules once daily for 28 days
Intervention: Placebo to QAW039 capsules once daily for 28 days (Drug)
3
Experimental
Fluticasone propionate inhaler twice daily for 28 days
Intervention: Fluticasone propionate inhaler twice daily for 28 days (Drug)
Outcomes
Primary Outcomes
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
Time Frame: 28 days
Secondary Outcomes
- To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.(28 days)
Investigators
Study Sites (2)
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