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Montelukast in Acute RSV Bronchiolitis

This study has been completed.
Sponsor:
Collaborator:
Wolfson Medical Center
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT00524693
First received: September 4, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

September 4, 2007
September 4, 2007
January 2006
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Length of stay [ Time Frame: hours ]
Same as current
No Changes Posted
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Montelukast in Acute RSV Bronchiolitis
A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Bronchiolitis
  • Drug: Montelukast
    4mg sachets
    Other Name: Singulair©
  • Drug: Placebo granules
  • Active Comparator: 1
    4mg Singulair© sachets
    Intervention: Drug: Montelukast
  • Placebo Comparator: 2
    Intervention: Drug: Placebo granules
Amirav I, Luder AS, Kruger N, Borovitch Y, Babai I, Miron D, Zuker M, Tal G, Mandelberg A. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. Pediatrics. 2008 Dec;122(6):e1249-55. Epub 2008 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
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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.
Both
up to 2 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00524693
HP-146-R
No
Not Provided
Ziv Hospital
Wolfson Medical Center
Principal Investigator: Israel Amirav, MD Ziv Medical Center
Ziv Hospital
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP