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

Last updated: April 2, 2025
Sponsor: Children's Hospital and Institute of Child Health, Multan
Overall Status: Completed

Phase

4

Condition

Common Cold

Asthma

Treatment

salbutamol + ipratropium bromide nebules

Salbutamol (Ventolin®)

Clinical Study ID

NCT06918418
U1111-1321-1030
  • Ages 2-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children with acute asthma exacerbation (presenting with wheeze, labored breathingwith ronchi audible on auscultation)

  • Within 12 hours of symptom onset

Exclusion

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 (pulmonaryasthma score ≥ 10, cases needing PICU care)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: salbutamol + ipratropium bromide nebules
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
July 15, 2024

Study 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.

Connect with a study center

  • Children's Hospital and Institute of Child Health

    Multan, Punjab 60000
    Pakistan

    Site Not Available

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