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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00076973
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiolitis Drug: montelukast sodium Drug: Comparator: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: montelukast sodium
    Duration of Treatment: 6 months
    Other Name: MK0476
  • Drug: Comparator: placebo
    Duration of Treatment: 6 months

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Symptom-Free Days

Secondary Outcome Measures :
  1. Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076973


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00076973    
Other Study ID Numbers: 0476-272
Formerly 0112BRS
MK0476-272
2004_098
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022
Keywords provided by Organon and Co:
RSV Bronchiolitis
Additional relevant MeSH terms:
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Bronchiolitis
Signs and Symptoms, Respiratory
Bronchitis
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Montelukast
 Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action