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A study comparing two types of inhalers for children and teenagers with asthma

Comparing the clinical efficacy of breath actuated inhalers versus metered dose inhalers with spacer in children and adolescents with asthma - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094687
Enrollment
70
Registered
2025-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: J45- Asthma

Interventions

Intervention1: Breath actuated inhaler: The Synchro Breathe is a type of breath-actuated metered-dose inhaler (BA-MDI) designed to release medication automatically upon detecting an inhalation effor

Sponsors

Government Medical College and Hospital Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 to 18 years with asthma diagnosed according to criteria in GINA 2024 Only patients requiring daily inhaled corticosteroids as controller

Exclusion criteria

Exclusion criteria: Acute exacerbation at enrolment Comorbid conditions affecting lung function eg cystic fibrosis ABPA Unable to perform spirometry Patients unlikely or unwilling to come for followup visits as planned

Design outcomes

Primary

MeasureTime frame
Change in FEV1 percent of expected from baselineTimepoint: 12 weeks—

Secondary

MeasureTime frame
Proportion of patients with asthma controlled, partly controlled or uncontrolledTimepoint: 2 4 12 weeks;Change in PEFR from baselineTimepoint: 2 4 12 weeks;Proportion of missed doses in previous 4 weeksTimepoint: 4 weeks;Proportion of steps correctly performedTimepoint: 2 4 12 weeks—

Countries

India

Contacts

Public ContactDr Tamanna Sharma

Government Medical College and Hospital, Chandigarh

shivanirandev@hotmail.com9914201318

Outcome results

None listed

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