Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: QAW039: Patients in the active cohort will take 3 capsules of 150mg QAW039 once a day. Fluticasone 100 μg twice daily would be given as background therapy.[Total Duration of therapy is
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Written informed consent must be obtained before any assessment is performed •Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening •Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment •An Asthma Control Questionnaire score >= 1.5 prior to treatment •Demonstration of reversible airway obstruction
Exclusion criteria
Exclusion criteria: •Pregnant or nursing (lactating) women •Acute illness other than asthma at the start of the study •Patients with clinically significant laboratory abnormalities at screening •Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation •Use of other investigational drugs at the time of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients. To assess the efficacy of QAW039 by Lung Function Assessed by trough Forced Expiratory Volume for 1 Second (FEV1) in non-atopic asthmaticsTimepoint: Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in asthma control as measured by the asthma control questionnaire (ACQ) from baseline to week 12.Timepoint: Baseline to Week 12 | — |
Countries
Belgium, Colombia, Czech Republic, Germany, India, Poland, Republic of Korea, Romania, South Africa, United States of America
Contacts
Public ContactMurugananthan K
Head Clinical Development in Novartis
Outcome results
None listed