Montelukast in Acute RSV Bronchiolitis
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Bronchiolitis |
Intervention | Drug: Montelukast Drug: Placebo granules |
Phase | N/A |
Sponsor | Ziv Hospital |
Responsible Party | Ziv Hospital |
ClinicalTrials.gov Identifier | NCT00524693 |
First Received | September 4, 2007 |
Last Updated | September 4, 2007 |
Last verified | September 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | September 4, 2007 |
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Last Updated Date | September 4, 2007 |
Start Date | January 2006 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Length of stay [Time Frame: hours] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Montelukast in Acute RSV Bronchiolitis |
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Official Title | A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis |
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 Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Bronchiolitis |
Intervention | Drug: Montelukast 4mg sachets Other Names: Singulair©Drug: Placebo granules |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 51 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility 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. |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | Not Provided |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00524693 |
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Other Study ID Numbers | HP-146-R |
Has Data Monitoring Committee | No |
Information Provided By | Ziv Hospital |
Study Sponsor | Ziv Hospital |
Collaborators | Wolfson Medical Center |
Investigators | Principal Investigator: Israel Amirav, MD Ziv Medical Center |
Verification Date | September 2007 |