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

NCT ID: NCT00076973

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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montelukast sodium

Duration of Treatment: 6 months

Intervention Type DRUG

Comparator: placebo

Duration of Treatment: 6 months

Intervention Type DRUG

Other Intervention Names

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MK0476

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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 the treatment of respiratory symptoms of post-respiratory syncytial virus bronchiolitis in children. Am J Respir Crit Care Med. 2008 Oct 15;178(8):854-60. doi: 10.1164/rccm.200706-910OC. Epub 2008 Jun 26.

Reference Type BACKGROUND
PMID: 18583576 (View on PubMed)

Other Identifiers

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Formerly 0112BRS

Identifier Type: -

Identifier Source: secondary_id

MK0476-272

Identifier Type: -

Identifier Source: secondary_id

2004_098

Identifier Type: -

Identifier Source: secondary_id

0476-272

Identifier Type: -

Identifier Source: org_study_id

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