Muscarinic and leukotrine antagonist in childhood asthma
Phase 3
- Conditions
- Health Condition 1: J454- Moderate persistent asthma
- Registration Number
- CTRI/2022/09/045331
- Lead Sponsor
- Rashmi Ranjan Das
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
persistent asthma symptoms (step 2 and step 3) despite ICS as per GINA 2021 guideline
Exclusion Criteria
(1) History of known hypersensitivity or contraindication to anti-cholinergic drugs
(2) Children with neuropsychiatry problems
(3) Use of oral steroid in past 6 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children with achievement of asthma control as assessed by C-ACTTimepoint: at the end of 3 months
- Secondary Outcome Measures
Name Time Method Adverse eventsTimepoint: 12 weeks (3 months) and 24 weeks (6 months);Asthma control as assessed by c-ACT scoreTimepoint: from baseline to the end of 12 (3 months) & 24 weeks (6 months);Cost-effectivenessTimepoint: 24 weeks (6 months);Improvement in FeV1Timepoint: 24 weeks (6 MONTHS) of treatment;Number of exacerbation as assessed by emergency department visits and use of reliever/rescue medication, oral steroidsTimepoint: 12 weeks (3 months) and 24 weeks (6 months);Quality of life <br/ ><br>Timepoint: 12 weeks (3 months) and 24 weeks (6 months)