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• Status: Withdrawn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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: KU Leuven; Maastricht University Medical Center; Université de Liège; Universiteit Antwerpen
• Treatments: Albuterol; Bronchodilator Agents

Criteria

Inclusion Criteria:

• Presenting to their primary care physician because of wheezing as confirmed by clinical examination (chest auscultation)

• A baseline score of 7 or higher on a parent-reported respiratory symptom score

Exclusion Criteria:

• Prematurity (<37 weeks)

• Major congenital malformations

• Pre-existing pulmonary disease as diagnosed by a paediatrician

• Continuous use of inhalation medication

• Physician visit because of wheezing in previous two weeks

• Use of inhalation medication in the previous two weeks

• Wheezing as a result of upper airway obstruction (i.e. laryngitis subglottica/pseudocroup)

• Severe illness requiring inhalation medication, prescription of antibiotics, or hospital referral during the consultation of inclusion