Efficacy, Safety, and Pharmacokinetics of QAW039 (NCT01253603) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety, and Pharmacokinetics of QAW039
United States170 participantsStarted 2010-11
Plain-language summary
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.