Urban Environmental Factors and Childhood Asthma - Full Text View

Purpose

The purpose of this study is to determine the way environmental factors 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 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 [ETS and 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.

Condition
Asthma Allergy

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Urban Environment and Childhood Asthma (URECA)

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Development of wheezing [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Fully define the rapidly evolving asthma phenotypes, and further delineate the role of risk factors related to environmental exposure, immune development, lung growth on the natural history of asthma and allergic diseases in urban minority children

Biospecimen Retention: Samples With DNA

Sample of umbilical cord blood (mother)
Maternal blood sample
Home environment inspection (environment)
Dust collection (environment)
Blood and nasal mucus collection (infant through age 10 years)
DNA sample of mother and child
Urine sample
Saliva sample
Induced sputum sample
Nasal epithelial cells sample

Estimated Enrollment:	500
Study Start Date:	January 2005
Estimated Study Completion Date:	March 2017
Estimated Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Inner city children

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114881

Locations

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston University School of Medicine
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
New York, New York, United States, 10029
United States, Wisconsin
University of Wisconsin- an administrative site
Madison, Wisconsin, United States, 53706

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Inner-City Asthma Consortium

Investigators

Principal Investigator:	Robert Wood, MD	Johns Hopkins University
Principal Investigator:	George T. O'Connor, MD, MS	Boston University
Principal Investigator:	Meyer Kattan, MD, CM	Columbia University School of Medicine
Principal Investigator:	Gordon Bloomberg, MD	Washington University School of Medicine
Principal Investigator:	James Gern, MD	University of Wisconsin, Madison
Principal Investigator:	Herman Mitchell, PhD	Rho Federal System Division, Inc.

More Information

Publications:

Mvula M, Larzelere M, Kraus M, Moisiewicz K, Morgan C, Pierce S, Post R, Nash T, Moore C. Prevalence of asthma and asthma-like symptoms in inner-city schoolchildren. J Asthma. 2005 Feb;42(1):9-16.

Chen E, Fisher EB, Bacharier LB, Strunk RC. Socioeconomic status, stress, and immune markers in adolescents with asthma. Psychosom Med. 2003 Nov-Dec;65(6):984-92.

Contreras JP, Ly NP, Gold DR, He H, Wand M, Weiss ST, Perkins DL, Platts-Mills TA, Finn PW. Allergen-induced cytokine production, atopic disease, IgE, and wheeze in children. J Allergy Clin Immunol. 2003 Dec;112(6):1072-7.

Federico MJ, Liu AH. Overcoming childhood asthma disparities of the inner-city poor. Pediatr Clin North Am. 2003 Jun;50(3):655-75, vii. Review.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00114881 History of Changes
Other Study ID Numbers:	DAIT ICAC-07
Study First Received:	June 17, 2005
Last Updated:	March 29, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Children
Urban Health
Pregnancy
Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013