Montelukast in Acute RSV Bronchiolitis

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

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
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:

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


Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both

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 identifier: NCT00524693

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

No publications provided by Ziv Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number): 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:
controlled clinical trial
Respiratory syncytial virus

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses processed this record on April 17, 2014