An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis

This study has been completed.

First Received: February 6, 2004 Last Updated: September 8, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00076973

Purpose

The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.

Condition	Intervention	Phase
Bronchiolitis	Drug: montelukast sodium Drug: Comparator: placebo	Phase III

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, 2-Period, Multicenter, Dble-Blind, Parallel-Group Study Comparing Effects of 2 Doses of MK0476 and Placebo in the Tx of Respiratory Symptoms Associated w/ Respiratory Syncytial Virus-Induced Bronchiolitis in Children 3 to 24 Mths

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of Symptom-Free Days

Secondary Outcome Measures:

Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days

Enrollment:	1125
Study Start Date:	July 2003
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 6 months

Eligibility

Ages Eligible for Study:	3 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalized or in an urgent/emergent-care setting at least 24 hours for a first or second episode of RSV-induced bronchiolitis. Approximately twenty percent of patients will be allowed in the study with a stay of less than 24 hours but need to meet a minimum predefined Respiratory Severity Score as required by the study.

Exclusion Criteria:

Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076973

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Bisgaard H, Flores-Nunez A, Goh A, Azimi P, Halkas A, Malice MP, Marchal JL, Dass SB, Reiss TF, Knorr BA. Study Of Montelukast for theTreatment of Respiratory Symptoms of Post-RSV-Bronchiolitis in Children. Am J Respir Crit Care Med. 2008 Jun 26; [Epub ahead of print]

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_098, Formerly 0112BRS, MK0476-272
Study First Received:	February 6, 2004
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00076973 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

RSV Bronchiolitis

Study placed in the following topic categories:

Bronchial Diseases
Hormone Antagonists
Bronchiolitis
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Hormones
Leukotriene Antagonists
Virus Diseases

Montelukast
Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Signs and Symptoms, Respiratory
Bronchitis

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Bronchiolitis
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions
Leukotriene Antagonists

Montelukast
Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Signs and Symptoms, Respiratory
Bronchitis

ClinicalTrials.gov processed this record on May 07, 2009