Efficacy, Safety, and Pharmacokinetics of QAW039

Novartis

Status and phase: Completed; Phase 2

Conditions: Persistent Asthma

Treatments: Drug: QAW039 capsules once daily for 28 days; Drug: Placebo to QAW039 capsules once daily for 28 days; Drug: Fluticasone propionate inhaler twice daily for 28 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253603

CQAW039A2201

2010-020177-16 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 170 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 3 patient groups

1

Experimental group

Description:

QAW039 capsules once daily for 28 days

Treatment:

Drug: QAW039 capsules once daily for 28 days

2

Experimental group

Description:

Placebo to QAW039 capsules once daily for 28 days

Treatment:

Drug: Placebo to QAW039 capsules once daily for 28 days

3

Experimental group

Description:

Fluticasone propionate inhaler twice daily for 28 days

Treatment:

Drug: Fluticasone propionate inhaler twice daily for 28 days