Wheezing in infants and young children (6-24 months old)
Conditions
Interventions
Trade Name: Ventolin
Pharmaceutical Form: Pressurised inhalation
Pharmaceutical form of the placebo: Pressurised inhalation
Route of administration of the placebo: Inhalation use
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Netherlands
Contacts
Public ContactClinical Trials Information
UMC Utrecht
Outcome results
None listed