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

NCT06918418 | Completed Phase 4

• 1 other identifier: U1111-1321-1030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Exacerbation; Children

Keywords

Asthma; Salbutamol; Ipratropium Bromide; Pulmonary Asthma Score

Outcome Measures

Primary Outcomes (1)

• Pulmonary Asthma Score (PAS)

  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.

  On presentation and four hours after treatment.

Study Arms (2)

Combined Nebulization

EXPERIMENTAL

Combined Salbutamol and Ipratropium Bromide

Drug: salbutamol + ipratropium bromide nebules

Single Nebulization

ACTIVE COMPARATOR

Salbutamol Nebulization alone

Drug: Salbutamol (Ventolin®)

Interventions

Salbutamol (Ventolin®) DRUG

Children were given 0.5% salbutamol aerosol solution (0.15 mg/kg weight, up to a maximum of 5 mg) in 5mL of normal saline solution for 7 min every 20 min for 2 h, and then every 30 min for two more hours. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask.

Also known as: Albuterol

Single Nebulization

salbutamol + ipratropium bromide nebules DRUG

In addition to Salbutamol nebulization, children received ipratropium bromide nebulization. Ipratropium bromide solution (250 mcg in children \<20 kg weight or 500 mcg in children \>=20 kg) every 20 min for the first 2 hours then every 30 min for 2 hours more will be given in between the salbutamol nebulization. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask.

Also known as: Albuterol, Atrovent

Combined Nebulization

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital and Institute of Child Health, Multan: lead

Study Sites (1)

Children's Hospital and Institute of Child Health

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (2)

• Iramain R, Lopez-Herce J, Coronel J, Spitters C, Guggiari J, Bogado N. Inhaled salbutamol plus ipratropium in moderate and severe asthma crises in children. J Asthma. 2011 Apr;48(3):298-303. doi: 10.3109/02770903.2011.555037. Epub 2011 Feb 21.

  PMID: 21332430 BACKGROUND

• Memon BN, Parkash A, Ahmed Khan KM, Gowa MA, Bai C. Response to nebulized salbutamol versus combination with ipratropium bromide in children with acute severe asthma. J Pak Med Assoc. 2016 Mar;66(3):243-6.

  PMID: 26968269 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Dr. Muhammad Aslam Sheikh, FCPS

  Children's Hospital and Institute of Child Health, Multan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)