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

Phase 3

Completed

• Conditions: Bronchiolitis

• Registration Number: NCT00076973
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2004-02-06
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Primary Completion: 2006-06
• Study Completion: 2006-10
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Symptom-Free Days

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days