Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)

January 31, 2022 updated by: Organon and Co

An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast

This is a prospective, multicenter, observational study in participants who completed the 24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of this study is to better understand the clinical and demographic correlates of asthma and atopic disorders in children (through the age of 6 years) with a history of severe RSV-induced bronchiolitis.

Study Overview

Status

Completed

Conditions

Respiratory Syncytial Virus Bronchiolitis

Study Type

Observational

Enrollment (Actual)

343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study sample includes participants who completed all visits of Protocol 272 from approximately 38 study sites worldwide. Participants enrolled in Protocol 272 were 3- to 24-month-old children with their first or second episode of "severe" RSV-induced bronchiolitis.

Description

Inclusion Criteria:

successfully completed MK-0476 Protocol 272
had RSV-induced bronchiolitis at entry into Protocol 272

Exclusion Criteria:

had developed or had been diagnosed with any illness or congenital disorder that could be immediately life threatening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
All Enrolled Participants All participants who completed Protocol 272 and were enrolled in Protocol 374

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor Time Frame: At 6 years of age	Asthma was defined as a positive response to the Epidemiology Questionnaire item "Has your child had wheezing or whistling in the chest in the past 6/12 months?" for the period of 12 months prior to age 6 years. Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.	At 6 years of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor Time Frame: At 6 years of age	Atopic disorders include allergic rhinitis (AR) and/or atopic dermatitis (AD). Atopic disorders was defined as a positive response to the Epidemiology Questionnaire item "In the past 6/12 months, has your child had a problem with sneezing or runny or blocked nose when he/she did not have a cold or the flu?" for AR and/or a positive response to both of the following items for AD: "Has your child had an itchy rash which was coming and going at any time in the past 6/12 months?" and "Has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears, or eyes?" for the period of 12 months prior to age 6 years. Prognostic factors for atopic disorders at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.	At 6 years of age
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor Time Frame: At 6 years of age	Use of Chronic Asthma Therapy for the period of 12 months prior to the age of 6 years was defined by clinical review of reported concomitant medications. Prognostic factors for use of chronic asthma therapy at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.	At 6 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lu S, Hartert TV, Everard ML, Giezek H, Nelsen L, Mehta A, Patel H, Knorr B, Reiss TF. Predictors of asthma following severe respiratory syncytial virus (RSV) bronchiolitis in early childhood. Pediatr Pulmonol. 2016 Dec;51(12):1382-1392. doi: 10.1002/ppul.23461. Epub 2016 May 6.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria