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

Children's Hospital and Institute of Child Health, Multan

Status and phase: Completed; Phase 4

Conditions: Asthma Exacerbation; Children

Treatments: Drug: salbutamol + ipratropium bromide nebules; Drug: Salbutamol (Ventolin®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06918418

U1111-1321-1030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Combined Nebulization

Experimental group

Description:

Combined Salbutamol and Ipratropium Bromide

Treatment:

Drug: salbutamol + ipratropium bromide nebules

Single Nebulization

Active Comparator group

Description:

Salbutamol Nebulization alone

Treatment:

Drug: Salbutamol (Ventolin®)