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

NCT04584034 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-07-23

No results posted yet for this study

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.

Conditions

  • Wheezing

Interventions

DRUG

Salbutamol

Salbutamol will be delivered using a Babyhaler spacer device. Ventolin will be used, brandname for Salbutamol sulfate. Ventolin contains the propellant HFA 134a.

DRUG

Placebo

The placebo will be delivered using a Babyhaler spacer device. The placebo will contain only the propellant HFA 134a.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • Université de Liège

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Roger AMJ Damoiseaux, Professor · Julius Center, UMC Utrecht

  • Ann van den Bruel, Professor · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584034 on ClinicalTrials.gov