Respiratory Syncytial Virus Bronchiolitis
Conditions
Keywords
Asthma
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.
Interventions
None listed
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor | 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 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants | 343 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 45.7 months STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 143 Participants |
| Sex: Female, Male Male | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 343 |
Outcome results
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.
Time frame: At 6 years of age
Population: All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | With Asthma at Age 6 Years | 6.1 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | Relative with Asthma: Yes | 11.2 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | Relative with Asthma: No | 3.1 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | Gender: Male | 9.6 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor | Gender: Female | 1.5 percentage of participants |
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.
Time frame: At 6 years of age
Population: All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor | With Atopic Disorders at Age 6 Years | 36.2 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor | History of AR: Yes | 65.1 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor | History of AR: No | 25.0 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor | Relative with Asthma: Yes | 47.4 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor | Relative with Asthma: No | 29.2 percentage of participants |
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.
Time frame: At 6 years of age
Population: All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | With Use of Chronic Asthma Therapy at Age 6 Years | 14.5 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | History of Asthma: Yes | 32.0 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | History of Asthma: No | 6.6 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | Region: Africa | 22.5 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | Region: Europe | 20.3 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | Region: South America | 15.9 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | Region: Asia/Pacific | 7.3 percentage of participants |
| All Enrolled Participants | Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor | Region: North & Central America | 5.7 percentage of participants |