Overview

Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial

Status:
Withdrawn

Trial end date:
2023-04-01

Target enrollment:

Participant gender:

Summary

Ten percent of infants are prescribed short-acting bronchodilators (i.e. salbutamol) for wheezing every year, yet evidence to support this treatment in children younger than two years old is scarce. The aim of this study is to evaluate the effectiveness and safety of salbutamol for treatment of wheezing in young children who present to their primary care physician. In this study, the investigators will compare the effect of a 7-day treatment with salbutamol to the effect of 7-day treatment with a placebo. The main effect will be measured by evaluating a parent-reported symptom score. Additionally, the investigators will look at the presence of wheeze after 5 days, time to recovery, adverse events, healthcare utilisation, medication prescriptions, cost-effectiveness, and parent satisfaction with treatment.

Phase:

Phase 4

Details

Lead Sponsor:

UMC Utrecht

Collaborators:

KU Leuven
Maastricht University Medical Center
Université de Liège
Universiteit Antwerpen

Treatments:

Albuterol
Bronchodilator Agents