Urban Environmental Factors and Childhood Asthma (URECA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00114881|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2005
Last Update Posted : January 18, 2020
|Condition or disease|
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.
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 Type :||Observational|
|Actual Enrollment :||609 participants|
|Official Title:||Urban Environment and Childhood Asthma (URECA)|
|Study Start Date :||January 2005|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
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
- Development of wheezing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 16 years of age ]Number of participants with the incidence (development) of asthma
- Occurrence of Specific Phenotypes of Asthma [ Time Frame: 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).
Biospecimen Retention: Samples With DNA
- Sample of umbilical cord blood (mother)
- Maternal blood sample
- Blood and nasal mucus collection (infant through age 14 or 16 years)
- DNA sample of mother and child
- Urine sample
- Saliva sample
- Induced sputum sample
- Nasal epithelial cells sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114881
|United States, Maryland|
|Pediatric Clinical Research Unit, Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, Missouri|
|Saint Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Study Chair:||James E. Gern, MD||University of Wisconsin, Madison|