Clinical trial NCT06918418: A Comparative Study of Adding Ipratropium to Salbutamol for the Treatment of Asthma Attack in Children
Official title: Comparison of Salbutamol Alone and Salbutamol in Combination With Ipratropium Bromide in Treatment of Acute Asthma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma Exacerbation
Children
Keywords: Asthma
Salbutamol
Ipratropium Bromide
Pulmonary Asthma Score
Lead sponsor: Children's Hospital and Institute of Child Health, Multan
Sponsor class: OTHER_GOV
First posted: 2025-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pulmonary Asthma Score (PAS)
timeFrame: On presentation and four hours after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Children's Hospital and Institute of Child Health
state: Punjab
Study officials:
affiliation: Children's Hospital and Institute of Child Health, Multan
name: Dr. Muhammad Aslam Sheikh, FCPS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.