Urban Environmental Factors and Childhood Asthma



Status:Active, not recruiting
Conditions:Allergy, Allergy, Asthma
Therapuetic Areas:Otolaryngology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:1/19/2019
Start Date:January 2005
End Date:July 2021

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Urban Environment and Childhood Asthma (URECA)

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.

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:

1. 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.

2. 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.

3. 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.

4. 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.

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
We found this trial at
4
sites
72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Boston, MA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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Saint Louis, Missouri 63110
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Saint Louis, MO
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