An Investigational Drug Study to Treat Respiratory Sympto... | NCT00076973

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

NCT00076973

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

1,125Actual

Phase

Phase 3

Conditions

Bronchiolitis

Interventions

montelukast sodium
Comparator: placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Jun 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Feb 6, 2004

First Submission Date that Met QC Criteria

Feb 13, 2004

First Posted Date

Feb 16, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 15, 2024Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,125Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
montelukast sodium	Drug	Duration of Treatment: 6 months		MK0476
Comparator: placebo	Drug	Duration of Treatment: 6 months

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Symptom-Free Days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

24 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18583576	Background	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.

ID	Type	Description	Link
Formerly 0112BRS
MK0476-272
2004_098

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases