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.
| Summary of results |
|---|
| The study ended early, before including participants, due to difficulties obtaining a suitable placebo-inhaler. |
| 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 |
Abandoned |
|
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 |
