Study on Beclomethasone inhalation treatment for patients with asthma.
Phase 4
Completed
- Conditions
- Health Condition 1: J454- Moderate persistent asthma
- Registration Number
- CTRI/2019/07/020117
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 208
Inclusion Criteria
1. Patients with Bronchial asthma receiving SABAs for at least three days in the last week.
2. Mild to Moderate bronchial asthma with post-bronchodilator FEV1 ( >80%) and Reversibility ( >12%)
Exclusion Criteria
1.Patients with < 1 follow up visit to be excluded from this concurrent analyses
2.Smoking or Non-smoking Risk factors including exposure to Biomass or Occupational hazard exposure
3.Patients on LTRAs &/or antihistamine combinations
4.Patients with hospitalization in the last four weeks for Uncontrolled asthma or requiring inhaled SABA of >=6 dosages in a day for the last week.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intergroup difference in both arms for patients requiring Rescue medications at 4th weekTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method 1.Treatment emergent adverse drug reactions at 4 weeks. <br/ ><br>2.Post bronchodilator FEV1 change at 4 weeks for both arms. <br/ ><br>3.Clinical responders (GINA score 1) from baseline at 4 weeks for both arms.Timepoint: 4 weeks