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

Organon

Status and phase: Completed; Phase 3

Conditions: Bronchiolitis

Treatments: Drug: montelukast sodium; Drug: Comparator: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076973

0476-272

Formerly 0112BRS

2004_098

MK0476-272

Details and patient eligibility

About

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.

Enrollment: 1,125 patients

Sex: All

Ages: 3 to 24 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind