Bronchodilators for wheeze in young childre

Phase 1

• Conditions: Wheezing in infants and young children (6-24 months old); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000313-33-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Otherwise healthy children aged 6-24 months presenting to their primary care physician because of wheezing as confirmed by clinical examination (chest auscultation) and a baseline score of 7 or higher on a parent-reported respiratory symptom score.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prematurity, 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, or use of asthma medication in the previous two weeks, wheezing as a result of upper airway obstruction (i.e. laryngitis subglottica/pseudocroup) and severe illness requiring inhalation medication, prescription of antibiotics, or hospital referral; during the consultation of inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: What is the (cost-)effectiveness of salbutamol inhalations (4x200µg for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing?;Secondary Objective: N.A.;Primary end point(s): The primary outcome is the course of the mean parent reported respiratory symptom score over 5 days. ;Timepoint(s) of evaluation of this end point: during 5 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes include [a] time to recovery (recovery defined as a respiratory symptom score of 5 or lower indicating only trivial symptoms), and adverse effects over the duration to the intervention (1 week), [b] healthcare utilisation (i.e. primary care physician re-consultations, medication prescriptions (e.g. antibiotics), specialist consultations and hospital admissions), and cost-effectiveness (4 weeks), and [c] the proportion of infants with persistent wheezing on auscultation at day 5 (included as objective outcome measure). ;Timepoint(s) of evaluation of this end point: during 28 days