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

Completed

• Conditions: Respiratory Syncytial Virus Bronchiolitis

• Registration Number: NCT01140048
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-08-31
• Results First Submitted QC: 2012-08-31
• Results First Posted: 2012-10-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor	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.
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor	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.