Mobile Observed inhaler Therapy in Poorly Controlled Asthma in Childre
Phase 3
- Conditions
- Health Condition 1: J454- Moderate persistent asthma
- Registration Number
- CTRI/2023/11/059430
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children of 5-18 years of age with physician diagnosed asthma, who have poor control as determined by Childhood Asthma control test (CACT) score of = 19 in children 5-11 years of age and Asthma Control Test (ACT) score of = 19 in children > 11 years of age.
2.Parents should have smart phone with internet facility and willing to send videos of technique.
Exclusion Criteria
1. Non able to come for follow up visits.
2. Using DPI or autohaler.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate improvement in ACT/CACT score using Mobile observed inhalation therapy in children of 5-18 years of age with poorly controlled asthma.Timepoint: one at baseline, 2nd at 1st month and 3rd at 3rd month.
- Secondary Outcome Measures
Name Time Method 1. To evaluate Asthma control as per GINA guidelinesTimepoint: at 12 weeks;2. To evaluate number of exacerbations requiring oral steroidsTimepoint: At 12 weeks;3. Number of exacerbations requiring emergency visits and/or hospitalizationTimepoint: At 12 weeks;4. To evaluate Lung functions: FEV1, FVC, FEV1/FVC., PEF, FEF25-75Timepoint: At 12 weeks;5. Improvement in compliance and technique of inhaler use.Timepoint: 12 weeks;6. Parental satisfactionTimepoint: at 12 weeks