An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 6, 2004
Last updated: January 21, 2016
Last verified: January 2016
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
Drug: montelukast sodium
Drug: Comparator: placebo
Phase 3

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 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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: August 2003
Study Completion Date: October 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: montelukast sodium
    Duration of Treatment: 6 months
    Other Name: MK0476
    Drug: Comparator: placebo
    Duration of Treatment: 6 months

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

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
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Please refer to this study by its identifier: NCT00076973

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00076973     History of Changes
Other Study ID Numbers: 0476-272  Formerly 0112BRS  MK0476-272  2004_098 
Study First Received: February 6, 2004
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
RSV Bronchiolitis

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on April 27, 2016