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

Respiratory Syncytial Virus Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140048
• Other study ID #: 0476-374
• Secondary ID: 2010_026MK-0476-
• Status: Completed
• Start date: October 2007
• Est. completion date: October 2011

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Syncytial Virus Bronchiolitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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