BeNeFIT18554: Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial - KIWI

Summary (French or English)

Does salbutamol help to reduce wheeze in young children?

One in 10 children below the age of 2 years are prescribed salbutamol by their GP because of wheezing. Salbutamol widens the airways and has a proven benefit in older children with wheezing due to asthma. It is unknown whether salbutamol is also effective in children younger than 2 years with wheezing. Salbutamol may have side effects and the administration of the inhaler using a face mask can be unpleasant for young children. Therefore, it is important to determine whether salbutamol is truly effective in this patient group. In this prospective randomised multicentre study we will evaluate the (cost-)effectiveness of salbutamol in young children with wheeze. We will compare the severity of the symptoms over time between two groups: treatment with salbutamol versus placebo (an identical inhaler containing no active drug). The trial will take place in primary care, in 40 practices in the Netherlands and Belgium. In the Netherland patients will be recruited by general practitioners. In Belgium many young children present directly to a community based paediatrician, hence children will be recruited by general practitioners and community paediatricians in Belgium.

Trial Description
Title

Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial

Participants (P)

Children who are otherwise healthy, aged 6-24 months, who present with physician-diagnosed wheeze at their GP/paediatrician’s surgery and have a baseline respiratory symptom score of at least 7 out of 18.

Intervention (I)

Salbutamol inhalation 4 times 200ug for 7 days

Control (C)

Placebo inhalation 4 times per day for 7 days

Outcome (O)

The course of the mean parent reported respiratory symptom score over 5 days

Trial Design

A primary care based, randomised, placebo-controlled, multicentre, parallel group trial

Sample Size

300 children (150 in The Netherlands, 150 in Belgium)

Trial duration

28 months

Budget

The Netherlands: 979,067 € including VAT

Belgium: 455,177 € including VAT

Status

Open

 

Trial team

Sponsor

University Medical Center Utrecht

Coordinating centre: University hospital Leuven

Chief Investigator

Roger Damoiseaux

National Coordinator BE: Ann Van den Bruel

 

Trial coordinator

Alma van de Pol

Sites

The Netherlands: 20 GP practices

Belgium: 20 sites which are either GP practices or community based paediatricians

External Partners

Liège Université, Unité de Recherche “Soins primaires et Santé

Maastricht University, Faculty of Health, Medicine and Life Sciences/ School Caphri, Care and Public Health  Research Institute/ Department of Family Medicine

Universiteit Antwerpen

Documents
Protocol  
Report

Q4 2021

Publication

Q1 2022

References

Clinicaltrials.gov: NCT04584034

Webpage: 

Funding scheme