Persistent Asthma
Conditions
Keywords
Asthma
Brief summary
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
Interventions
DRUGQAW039 capsules once daily for 28 days
DRUGPlacebo to QAW039 capsules once daily for 28 days
DRUGFluticasone propionate inhaler twice daily for 28 days
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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/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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms. | 28 days |
Countries
Belgium, Germany, Romania, South Korea, United States
Outcome results
None listed