Montelukast in Acute RSV Bronchiolitis
Information source: Ziv Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiolitis
Intervention: Montelukast (Drug); Placebo granules (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ziv Hospital Official(s) and/or principal investigator(s):
Israel Amirav, MD, Principal Investigator, Affiliation: Ziv Medical Center
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.
Clinical Details
Official title: A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Length of stay
Eligibility
Minimum age: N/A.
Maximum age: 2 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: January 2006
Last updated: September 4, 2007
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