Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Wheezing
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Individually randomised, placebo-controlled, multicentre, parallel group trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 624 years
Gender
Both males and females

Description

BACKGROUND: Worldwide, 30% of all infants and young children experience an episode of wheezing (Matricaldi et al. 2008; Mallol at al. 2010; Martinez et al. 1995). Currently, there is no evidence to underpin the management of these children. National Belgian and Dutch primary care professional guidel...

BACKGROUND: Worldwide, 30% of all infants and young children experience an episode of wheezing (Matricaldi et al. 2008; Mallol at al. 2010; Martinez et al. 1995). Currently, there is no evidence to underpin the management of these children. National Belgian and Dutch primary care professional guidelines propose 'a trial of treatment' with short acting bronchodilators (i.e. salbutamol) for wheezing children below the age of six years and to evaluate treatment effect after 1 to 2 weeks, but convincing evidence is lacking (Chavasse et al. 2002). The effect of salbutamol has been studied well in children with proven asthma and is considered the first-line treatment in all patients in international asthma guidelines. However, trial findings of children with asthma are not applicable to primary care infants and young children with acute wheeze for several reasons; the anatomy and physiology in younger children differs significantly from those in older children and many infants and young children with an acute episode of wheezing do not experience further wheezing episodes later in life. As a result, it is at present unclear whether salbutamol inhalation therapy confers any benefit in young children who wheeze. OBJECTIVE: To evaluate the (cost-)effectiveness of salbutamol inhalations (4x200?g for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing. DESIGN: A primary care based, randomised, placebo-controlled, multicentre, parallel group trial in 40 general practices and community paediatric practices in Belgium and the Netherlands.

Tracking Information

NCT #
NCT04584034
Collaborators
  • KU Leuven
  • Maastricht University Medical Center
  • Universiteit Antwerpen
  • Université de Liège
Investigators
Principal Investigator: Roger AMJ Damoiseaux, Professor Julius Center, UMC Utrecht Principal Investigator: Ann van den Bruel, Professor KU Leuven