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

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ClinicalTrials.gov Identifier: NCT01140048
Recruitment Status : Completed
First Posted : June 9, 2010
Results First Posted : October 5, 2012
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

June 7, 2010
June 9, 2010
August 31, 2012
October 5, 2012
July 20, 2016
October 2007
October 2011   (Final data collection date for primary outcome measure)
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.

The percentage of patients with asthma by prognostic factor [ Time Frame: At 6 years of age ]
Complete list of historical versions of study NCT01140048 on ClinicalTrials.gov Archive Site
  • 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.

  • 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.

  • The percentage of patients with atopic disorders by prognostic factor [ Time Frame: At 6 years of age ]
  • The percentage of patients with use of chronic asthma therapy by prognostic factor [ Time Frame: At 6 years of age ]
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Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
Respiratory Syncytial Virus Bronchiolitis
Not Provided
All Enrolled Participants
All participants who completed Protocol 272 and were enrolled in Protocol 374
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
343
345
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Months to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01140048
0476-374
2010_026 ( Other Identifier: Merck Registration ID )
MK-0476-374 ( Other Identifier: Meck Protocol ID )
No
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2016