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NCT00524693 Clinical Trial

Montelukast in Acute RSV Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00524693
Other study ID # HP-146-R
Secondary ID
Status Completed
Phase N/A
First received September 4, 2007
Last updated September 4, 2007
Start date January 2006

Study information
Verified date September 2007
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A to 2 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast
4mg sachets
• Placebo granules

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ziv Hospital Wolfson Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Length of stay hours
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