N/A
N=343
Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)
Respiratory Syncytial Virus Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT01140048 ↗Enrolled (actual)
343
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor — 6.1; 11.2; 3.1; 9.6 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor |
6.1; 11.2; 3.1; 9.6; 1.5 | — |
| SECONDARY Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor |
36.2; 65.1; 25.0; 47.4; 29.2 | — |
| SECONDARY Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor |
14.5; 32.0; 6.6; 22.5; 20.3; 15.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01140048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.