A clinical study to assess the efficacy and safety of QGE031 administered subcutaneously in Asthma patients not adequately controlled with inhaed corticosteroids.
Phase 2
- Conditions
- Health Condition 1: null- Asthma
- Registration Number
- CTRI/2015/03/005617
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 457
Inclusion Criteria
•A diagnosis of allergic asthma , uncontrolled on current medication.
•History of at least 1 asthma exacerbation during the last 1 year
•Forced Expiratory Volume in one second (FEV1) of >= 40% and <= 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).
Exclusion Criteria
•Baseline IgE levels or body weight outside the omalizumab dosing table.
•Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
•Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in response rate of QGE031 compared to placebo from baseline to week 16Timepoint: Baseline and Week 16
- Secondary Outcome Measures
Name Time Method â?¢QGE031 ACQ response rate compared to omalizumabTimepoint: Baseline, week 16