Bronchiolitis
Conditions
Keywords
Bronchiolitis, controlled clinical trial, pediatrics, Infants, montelukast, Respiratory syncytial virus
Brief summary
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.
Interventions
DRUGMontelukast
4mg sachets
DRUGPlacebo granules
Sponsors
Wolfson Medical Center
Ziv Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 2 Years
Inclusion criteria
* Age \> 4 weeks \< 2 years * Duration of respiratory symptoms \< 4 days * Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales * First episode of wheezing or shortness of breath * Randomization within 12 hours of admission * No need for steroid treatment in the ward * Informed consent
Exclusion criteria
* A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness). * Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of stay | hours |
Outcome results
None listed