Home spray inhalation in High risk asthma
Phase 4
Completed
- Conditions
- Health Condition 1: J455- Severe persistent asthma
- Registration Number
- CTRI/2018/11/016319
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adults with Moderate to Severe Br. asthma ie. poorly controlled receiving low or med-dose
ICS/LABA with history of Oral Steroid use or Hospitalization or Frequent use of rescue
medications for exacerbations
Exclusion Criteria
Patients with < 1 follow up visit to be excluded from this Retrospective analyses
Smoking or Non-smoking Risk factors including exposure to Biomass or Occupational hazard
exposure
Patients on LTRAs &/or antihistamine combinations
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a. FEVl improvement at 8 wks <br/ ><br>b. PEFR improvement at 4 & 8 wks <br/ ><br>c. Change in GINA assessment score at 4 and 8 wks <br/ ><br>d. TEAE (2 %) at 12 wksTimepoint: 4 weeks <br/ ><br>8 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method TEAE (2 %) at 12 wksTimepoint: 12 weeks