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A study comparing two inhaler treatments Budesonide Formoterol and Salmeterol Fluticasone for improving asthma control in children

A Quasi Experimental Study Comparing the Effectiveness of Budesonide Formoterol versus Salmeterol Fluticasone in Children with Bronchial Asthma - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111974
Enrollment
60
Registered
2026-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: Budesonide + Formoterol: Group A Budesonide Formoterol 100 mcg plus 6 mcg Two puffs twice daily Route Inhalation Duration 12 weeks Control Intervention1: Salmeterol + Fluticasone: Group

Sponsors

Shri Sathya Sai Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children diagnosed with bronchial asthma Age group according to your protocol Patients attending pediatric OPD and IPD Patients whose parents guardians provide informed consent

Exclusion criteria

Exclusion criteria: Children with severe systemic illness Known hypersensitivity to study drugs Children with other chronic respiratory disorders Patients unwilling to participate Poor treatment compliance or inability to follow up

Design outcomes

Primary

MeasureTime frame
1Improvement in asthma control among children receiving Budesonide Formoterol versus Salmeterol Fluticasone therapy Timepoint: Baseline and after 3 months

Secondary

MeasureTime frame
1Improvement in pulmonary function tests such as PEFR/FEV1 2Reduction in frequency of acute asthma exacerbations 3Reduction in use of rescue medications 4Assessment of adverse drug reactions and tolerability 5Improvement in symptom score and quality of life Timepoint: 1Baseline and after 3 months 2During follow up period 3Baseline and after 3 months 4Throughout study period 5Baseline and after 3 months

Countries

India

Contacts

Public ContactDr Gonuguntla Divya Vani

Shri Sathya Sai Medical College and Research Institute

vidyavv87@gmail.com9840320080

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026