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

NCT ID: NCT01140048

Last Updated: 2022-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-10-31

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.

Detailed Description

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Conditions

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Respiratory Syncytial Virus Bronchiolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Enrolled Participants

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

No interventions assigned to this group

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
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 27152482 (View on PubMed)

Other Identifiers

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2010_026

Identifier Type: OTHER

Identifier Source: secondary_id

MK-0476-374

Identifier Type: OTHER

Identifier Source: secondary_id

0476-374

Identifier Type: -

Identifier Source: org_study_id

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