URECA: Urban Environmental Factors and Childhood Asthma

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Active, not recruiting

CT.gov ID

NCT00114881

Collaborator

Inner-City Asthma Consortium (Other), Rho Federal Systems Division, Inc. (Industry)

560

Enrollment

Locations

237.9

Anticipated Duration (Months)

140

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Minority children who grow up in poor urban neighborhoods have the highest rates of asthma, and also experience greater morbidity from acute exacerbations of this disease. The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of wheezing, atopy and asthma for purposes of identifying new strategies for asthma prevention.

Condition or Disease	Intervention/Treatment	Phase
Asthma Allergy

Detailed Description

The purpose of this study is to determine the way environmental factors (like the components of inner-city household dust) affect immune system development and symptoms of asthma in inner city children. The study is divided into three periods, as the subjects age from birth to 10 years old. Each age bracket will explore different objectives and endpoints.

Study Objectives/Hypotheses:

Subjects age 0 to 3 years old:

Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by age 3.
Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6.

Subjects age 4 to 7 years old:

There is a unique pattern of immune development that is driven by specific urban exposures in early life, and this pattern of immune development is characterized by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age, and these characteristics synergistically increase the risk of asthma at age 7 years.

Subjects age 7 to 10 years old:

There are unique combinations of environmental exposures (cockroach allergens, indoor pollutants [Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)], lack of microbial exposure), and family characteristics (stress, genetic factors related to innate immunity) that synergistically promote asthma onset, persistence, and morbidity in urban neighborhoods. These exposures and characteristics influence immune expression and lung development during critical periods of growth, resulting in specific asthma phenotypes.

Subjects age 10 to 16 years old:

To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.

Study Design

Study Type:

Observational

Actual Enrollment :

560 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Urban Environment and Childhood Asthma (URECA)

Actual Study Start Date :

Feb 2, 2005

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Inner-city children with asthma Children at high risk for developing allergic diseases and asthma, on the basis of a parental history of asthma, allergic rhinitis or atopic dermatitis, and residence in the inner city

Outcome Measures

Primary Outcome Measures

Development of wheezing [0 to 3 years of age]
Establish in inner city children the immunologic causes for the development of recurrent wheezing.
Correlation of Immunologic Factors and Development of Asthma [by 7 years of age]
Establish, in this cohort of inner-city children, the immunologic causes for the development of asthma at age 7
Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes [up to 10 years of age]
Fully define the rapidly evolving asthma phenotypes and further delineate the role of risk factors related to environmental exposure (e.g.; house dust levels found through home inspection), immune development, lung growth on the natural history of asthma and allergic diseases in urban minority children
Incidence of Asthma [up to 16 years of age]
Number of participants with the incidence (development) of asthma
Occurrence of Specific Phenotypes of Asthma [up to 16 years of age]
Further define asthma phenotypes based on the findings in Inner-city Asthma Consortium-19 (ICAC-19) (Asthma Phenotypes in the Inner City (APIC), ClinicalTrials.gov Identifier NCT01383941).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for Mothers:

Plan to give birth at the study hospital
Have asthma, hay fever, or eczema (or infant's father has any of these diseases)
Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
At least 34 weeks pregnant at time of delivery
Willing to allow an umbilical cord blood specimen to be obtained from her infant
Willing to comply with all study requirements
Have access to a phone
Speak English. Spanish-speaking participants enrolled at sites with Spanish-speaking staff are also eligible.

Exclusion Criteria for Mothers:

HIV infected at the time of delivery
Plan to move out of the geographic area during the study

Exclusion Criteria for Infants:

Respiratory distress requiring intubation and ventilation for 4 hours or more
Respiratory distress requiring either supplemental oxygen or continuous positive airway pressure (CPAP) for 4 days or more
Pneumonia requiring antibiotic treatment for 1 week or more
Significant congenital abnormality
Received palivizumab for respiratory syncytial virus prophylaxis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Clinical Research Unit, Johns Hopkins University	Baltimore	Maryland	United States	21287
2	Boston Medical Center	Boston	Massachusetts	United States	02118
3	Saint Louis Children's Hospital	Saint Louis	Missouri	United States	63110
4	Columbia University Medical Center	New York	New York	United States	10032