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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Syncytial Virus Bronchiolitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Enrolled Participants<br>All participants who completed Protocol 272 and were enrolled in Protocol 374 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma