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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00076973

Enrollment

1125

Registered

2004-02-16

Start date

2003-08-31

Completion date

2006-10-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

RSV Bronchiolitis

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.

Interventions

DRUGmontelukast sodium

Duration of Treatment: 6 months

DRUGComparator: placebo

Duration of Treatment: 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Months to 24 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage of Symptom-Free Days	—

Secondary

Measure	Time frame
Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026