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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
  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.


Condition Intervention
Bronchiolitis
 Drug: Montelukast
Drug: Placebo granules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Length of stay [ Time Frame: hours ]

Enrollment: 51
Study Start Date: January 2006
Arms Assigned Interventions
Active Comparator: 1
4mg Singulair© sachets
 Drug: Montelukast
4mg sachets
Other Name: Singulair©
Placebo Comparator: 2 Drug: Placebo granules

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524693

Sponsors and Collaborators
Ziv Hospital
Wolfson Medical Center
Investigators
Principal Investigator: Israel Amirav, MD Ziv Medical Center
  More Information

No publications provided by Ziv Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00524693     History of Changes
Other Study ID Numbers: HP-146-R
Study First Received: September 4, 2007
Last Updated: September 4, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Ziv Hospital:
Bronchiolitis
controlled clinical trial
pediatrics
 Infants
montelukast
Respiratory syncytial virus

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Montelukast
 Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013