NCT00076973

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,125

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2003

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2004

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

February 6, 2004

Last Update Submit

August 12, 2024

Conditions

Bronchiolitis

Keywords

RSV Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Symptom-Free Days

Secondary Outcomes (1)

  • Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days

Interventions

montelukast sodiumDRUG

Duration of Treatment: 6 months

Also known as: MK0476
Comparator: placeboDRUG

Duration of Treatment: 6 months

Eligibility Criteria

Age3 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 18583576BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Interventions

montelukast

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2004

First Posted

February 16, 2004

Study Start

August 1, 2003

Primary Completion

June 1, 2006

Study Completion

October 1, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02