Montelukast in Acute RSV Bronchiolitis

This study has been completed.

First Received on September 4, 2007. No Changes Posted

Sponsor:	Ziv Hospital
Collaborator:	Wolfson Medical Center
Information provided by:	Ziv Hospital
ClinicalTrials.gov Identifier:	NCT00524693

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:

Drug Information available for: Montelukast sodium Montelukast

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):

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.

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 February 09, 2012