This trial is active, not recruiting.

Conditions asthma, allergy
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Inner-City Asthma Consortium
Start date January 2005
End date July 2021
Trial size 609 participants
Trial identifier NCT00114881, DAIT ICAC-07


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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

Primary Outcomes

Development of wheezing
time frame: 0 to 3 years of age
Correlation of Immunologic Factors and Development of Asthma
time frame: by 7 years of age
Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes
time frame: up to 10 years of age
Incidence of Asthma
time frame: up to 16 years of age
Occurrence of Specific Phenotypes of Asthma
time frame: up to 16 years of age

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Urban Environment and Childhood Asthma (URECA)
Principal investigator Leonard B. Bacharier, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).