Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial.
Phase 4
Withdrawn
- Conditions
- respiratory tract infectionswheeze1004743810024970
- Registration Number
- NL-OMON49680
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
-children aged 6-24 months
- wheezing as confirmed by clinical examination (chest auscultation)
- a score of 7 or higher on a parent-reported respiratory symptom score.
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)
- severe illness requiring inhalation medication, prescription of antibiotics,
or hospital referral; during the consultation of inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the course of the mean parent reported respiratory<br /><br>symptom score over 5 days.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes include [a] time to recovery (recovery defined as a<br /><br>respiratory symptom score of 5 or lower indicating only trivial symptoms), and<br /><br>adverse effects over the duration to the intervention (1 week), [b] healthcare<br /><br>utilisation (i.e. primary care physician re-consultations, medication<br /><br>prescriptions (e.g. antibiotics), specialist consultations and hospital<br /><br>admissions), and cost-effectiveness (4 weeks), and [c] the proportion of<br /><br>infants with persistent wheezing on auscultation at day 5 (included as<br /><br>objective outcome measure). </p><br>