Clinical Trials Directory

Trials / Completed

CompletedNCT00114881

Urban Environmental Factors and Childhood Asthma

Urban Environment and Childhood Asthma (URECA)

Status
Completed
Phase
Study type
Observational
Enrollment
560 (actual)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Sex
All
Age
Healthy volunteers
Accepted

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.

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 five periods, as the subjects age from birth to 17 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. 5. Subjects to age 17 (Continuation of phase 4 to follow participants to age 17) To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.

Conditions

Timeline

Start date
2005-02-02
Primary completion
2024-08-31
Completion
2024-08-31
First posted
2005-06-20
Last updated
2025-07-18

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00114881. Inclusion in this directory is not an endorsement.