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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01140048
• Collaborator: (none)
• Enrollment: 343
• Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Bronchiolitis

Study Design

• Study Type: Observational
• Actual Enrollment: 343 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
All Enrolled Participants All participants who completed Protocol 272 and were enrolled in Protocol 374

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months to 6 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme Corp.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01140048
• Other Study ID Numbers: 0476-374; 2010_026; MK-0476-374
• First Posted: Jun 9, 2010
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Organon and Co: Asthma
• Additional relevant MeSH terms: Bronchiolitis

Study Results

Participant Flow

Arm/Group Title	All Enrolled Participants
Arm/Group Description
Period Title: Overall Study
STARTED	343
COMPLETED	298
NOT COMPLETED	45

Baseline Characteristics

Arm/Group Title	All Enrolled Participants
Arm/Group Description
Overall Participants	343
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	45.7 (10.0)
Sex: Female, Male (Count of Participants)
Female	143 41.7%
Male	200 58.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.

Arm/Group Title	All Enrolled Participants
Arm/Group Description
Measure Participants	309
With Asthma at Age 6 Years	6.1 1.8%
Relative with Asthma: Yes	11.2 3.3%
Relative with Asthma: No	3.1 0.9%
Gender: Male	9.6 2.8%
Gender: Female	1.5 0.4%

2. Secondary Outcome

Title	Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.

Arm/Group Title	All Enrolled Participants
Arm/Group Description
Measure Participants	309
With Atopic Disorders at Age 6 Years	36.2 10.6%
History of AR: Yes	65.1 19%
History of AR: No	25.0 7.3%
Relative with Asthma: Yes	47.4 13.8%
Relative with Asthma: No	29.2 8.5%

3. Secondary Outcome

Title	Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.

Arm/Group Title	All Enrolled Participants
Arm/Group Description
Measure Participants	310
With Use of Chronic Asthma Therapy at Age 6 Years	14.5 4.2%
History of Asthma: Yes	32.0 9.3%
History of Asthma: No	6.6 1.9%
Region: Africa	22.5 6.6%
Region: Europe	20.3 5.9%
Region: South America	15.9 4.6%
Region: Asia/Pacific	7.3 2.1%
Region: North & Central America	5.7 1.7%

Adverse Events

Time Frame	Serious adverse events that occurred within 24 hours following a study procedure
Adverse Event Reporting Description	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.
Arm/Group Title	All Enrolled Participants
Arm/Group Description
All Cause Mortality
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/343 (0%)
Other (Not Including Serious) Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.