To assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose of inhaled corticosteroids (ICS) as background therapy.
- Conditions
- Health Condition 1: null- Asthma
- Registration Number
- CTRI/2014/07/004743
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 336
•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
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients. <br/ ><br> <br/ ><br>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 Outcome Measures
Name Time Method 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