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

NCT01140048 | Completed Results

• 3 other identifiers: 0476-3742010_026MK-0476-374
• Study Type: observational
• Target: 343
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Syncytial Virus Bronchiolitis

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor

  At 6 years of age

• Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor

  At 6 years of age

Study Arms (1)

All Enrolled Participants

All participants who completed Protocol 272 and were enrolled in Protocol 374

Eligibility Criteria

• Age: 18 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Organon and Co: lead

Related 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.23461. Epub 2016 May 6.

  PMID: 27152482 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: October 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 2, 2022
• Results First Posted: October 5, 2012

Record last verified: 2022-01