Montelukast in Acute RSV Bronchiolitis
- Registration Number
- NCT00524693
- Lead Sponsor
- Ziv Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Montelukast 4mg Singulair© sachets 2 Placebo granules -
- Primary Outcome Measures
Name Time Method Length of stay hours
- Secondary Outcome Measures
Name Time Method