Real world evidence on Asthama Inhaler
Not Applicable
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2023/06/053990
- Lead Sponsor
- Zydus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients eligible for medication
Exclusion Criteria
Hypersensitivity to active substance
Primary treatment of status asthmatics or acute episodes of asthma where intensive measures are required
Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spirometry changes <br/ ><br>Quality of Life Questionnaire <br/ ><br>Number of rescue medication-free days during the treatment period <br/ ><br>Global impression of change in the disease condition by the patients at 12 weeks <br/ ><br>Modified Physician’s Global Evaluation of Treatment Effectiveness (mGETE) at 12 weeks <br/ ><br>Adverse and Serious adverse events reported during the study duration <br/ ><br>Asthma exacerbations reported during the study durationTimepoint: Baseline, 4 weeks & 12 weeks
- Secondary Outcome Measures
Name Time Method ATimepoint: NA