A Comparative Study of Adding Ipratropium to Salbutamol for the Treatment of Asthma Attack in Children

Phase 4

Completed

• Conditions: Asthma Exacerbation; Children
• Interventions: Drug: salbutamol + ipratropium bromide nebules; Drug: Salbutamol (Ventolin®)

• Registration Number: NCT06918418
• Lead Sponsor: Children's Hospital and Institute of Child Health, Multan

Brief Summary

The goal of this clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children.

The main question this study aimed to answer was:

Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone?

Researchers compared salbutamol alone to a combination of salbutamol and ipratropium in children with acute asthma.

Participants:

(i) Received either salbutamol alone or salbutamol with ipratropium via nebulization for 4 hours

(ii) Had their asthma symptoms assessed before and after treatment

(iii) Were discharged with continued treatment and counseling if stable

This study was conducted in the Department of Pediatric Medicine, Children's Hospital Multan, over six months. A total of 60 children with acute asthma were included.

Detailed Description

Children presenting with asthma exacerbation were assessed for eligibility. Eligible participants had their baseline characteristics recorded including age, gender, history of parental asthma, duration of asthma diagnosis, use of asthma controllers (inhaled corticosteroids, Long Acting Beta Agonist (LABA), Montelukast) \& baseline pulmonary asthma score. Through lottery method using sequentially numbered sealed opaque envelopes children were assigned to group A and group B treatments. At the end of 4-hours of therapy, pulmonary asthma score was re-assessed by pediatrician not aware of treatment assigned. Once stabilized, the children were discharged on regular nebulization therapy with controller medication after proper counseling.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children with acute asthma exacerbation (presenting with wheeze, labored breathing with ronchi audible on auscultation)
• Within 12 hours of symptom onset

Exclusion Criteria

• Children with known pulmonary and/or cardiac congenital malformations
• Bronchopulmonary dysplasia
• Cystic fibrosis
• Post infectious bronchiolitis obliterans
• Altered mental status on presentation with imminent respiratory failure (pulmonary asthma score ≥ 10, cases needing PICU care)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Nebulization	salbutamol + ipratropium bromide nebules	Combined Salbutamol and Ipratropium Bromide
Single Nebulization	Salbutamol (Ventolin®)	Salbutamol Nebulization alone

Primary Outcome Measures

Name	Time	Method
Pulmonary Asthma Score (PAS)	On presentation and four hours after treatment.	Asthma severity was assessed using Pulmonary Asthma score. It uses respiratory rate, wheezing, inspiration to expiration ratio (I:E) and use of accessory muscles graded 0 - 3 with total score of 12.

Trial Locations

Locations (1)

Children's Hospital and Institute of Child Health; 🇵🇰 Multan, Punjab, Pakistan