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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_026 | Other Identifier | Merck Registration ID | |
| MK-0476-374 | Other Identifier | Meck Protocol ID |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants | All participants who completed Protocol 272 and were enrolled in Protocol 374 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27152482 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available. | Posted | Number | percentage of participants | At 6 years of age |
|
Serious adverse events that occurred within 24 hours following a study procedure
Only serious adverse events related to study-defined procedures that occurred within 24 hours following the procedure were to be reported. Information on non-serious adverse events was not to be collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| At 6 years of age |
| 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 |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| 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. | All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available. | Posted | Number | percentage of participants | At 6 years of age |
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|
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| 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. | All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available. | Posted | Number | percentage of participants | At 6 years of age |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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| Relative with Asthma: Yes |
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| Relative with Asthma: No |
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| Title | Measurements |
|---|---|
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| Region: Africa |
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| Region: Europe |
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| Region: South America |
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| Region: Asia/Pacific |
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| Region: North & Central America |
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