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
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