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NCT00076973 Clinical Trial

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

Bronchiolitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00076973
Other study ID # 0476-272
Secondary ID Formerly 0112BRS
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2003
Est. completion date October 2006

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1125
Est. completion date October 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 3 Months to 24 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast sodium
Duration of Treatment: 6 months
• Comparator: placebo
Duration of Treatment: 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Symptom-Free Days
Secondary Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days
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