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NCT Number: NCT06918418

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

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.

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Key information

Conditions

Asthma Exacerbation Asthma Bronchial Diseases Children Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital and Institute of Child Health

Multan, Punjab Province, 60000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Albuterol

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.

Other names: Albuterol, Atrovent

Primary outcomes

  1. Pulmonary Asthma Score (PAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital and Institute of Child Health, Multan

Other Gov

Registry information

Official study title

Comparison of Salbutamol Alone and Salbutamol in Combination With Ipratropium Bromide in Treatment of Acute Asthma in Children

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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