Montelukast in Acute RSV Bronchiolitis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 4, 2007

Last Updated Date

September 4, 2007

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Length of stay [ Time Frame: hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Montelukast in Acute RSV Bronchiolitis

Official Title ^ICMJE

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bronchiolitis

Intervention ^ICMJE

Drug: Montelukast
Drug: Placebo granules

Study Arms / Comparison Groups

Active Comparator: 4mg Singulair© sachets

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

up to 2 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00524693

Responsible Party

Study ID Numbers ^ICMJE

HP-146-R

Study Sponsor ^ICMJE

Ziv Hospital

Collaborators ^ICMJE

Wolfson Medical Center

Investigators ^ICMJE

Principal Investigator:

Israel Amirav, MD

Ziv Medical Center

Information Provided By

Ziv Hospital

Verification Date

September 2007

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