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Mobile Observed inhaler Therapy in Poorly Controlled Asthma in Children

Mobile Observed Inhalational Therapy in Poorly Controlled Asthma in Children (MOBIT): A Randomized Controlled Trial - MOBIT

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059430
Enrollment
44
Registered
2023-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J454- Moderate persistent asthma

Interventions

Intervention1: standard therapy with salbutamol or budecort or forcort. Mobile video based observation of inhalation technique: Inhalational therapy,doages will vary based on patient condition. Patien

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Non able to come for follow up visits. 2. Using DPI or autohaler.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Kana Ram Jat

AIIMS New Delhi

drkanaram@gmail.com01129576822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026