Urban Environmental Factors and Childhood Asthma

NCT ID: NCT00114881

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 560 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-02-02
• Study Completion Date: 2024-08-31

Brief 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

Asthma; Allergy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• HIV infected at the time of delivery
• Plan to move out of the geographic area during the study

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inner-City Asthma Consortium

NETWORK

Sponsor Role: collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James E. Gern, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

Pediatric Clinical Research Unit, Johns Hopkins University

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Saint Louis Children's Hospital

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

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Sumino K, Tucker J, Shahab M, Jaffee KF, Visness CM, Gern JE, Bloomberg GR, Holtzman MJ. Antiviral IFN-gamma responses of monocytes at birth predict respiratory tract illness in the first year of life. J Allergy Clin Immunol. 2012 May;129(5):1267-1273.e1. doi: 10.1016/j.jaci.2012.02.033. Epub 2012 Mar 27.

Reference Type: RESULT

PMID: 22460071 (View on PubMed)

Chi A, Wildfire J, McLoughlin R, Wood RA, Bloomberg GR, Kattan M, Gergen P, Gold DR, Witter F, Chen T, Holick M, Visness C, Gern J, O'Connor GT. Umbilical cord plasma 25-hydroxyvitamin D concentration and immune function at birth: the Urban Environment and Childhood Asthma study. Clin Exp Allergy. 2011 Jun;41(6):842-50. doi: 10.1111/j.1365-2222.2011.03712.x. Epub 2011 Apr 11.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 20194818 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Bacharier LB, Beigelman A, Calatroni A, Jackson DJ, Gergen PJ, O'Connor GT, Kattan M, Wood RA, Sandel MT, Lynch SV, Fujimura KE, Fadrosh DW, Santee CA, Boushey H, Visness CM, Gern JE; NIAID sponsored Inner-City Asthma Consortium. Longitudinal Phenotypes of Respiratory Health in a High-Risk Urban Birth Cohort. Am J Respir Crit Care Med. 2019 Jan 1;199(1):71-82. doi: 10.1164/rccm.201801-0190OC.

Reference Type: RESULT

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT), NIAID

Other Identifiers

NIAID CRMS ID#: 20126

Identifier Type: OTHER

Identifier Source: secondary_id

DAIT ICAC-07

Identifier Type: -

Identifier Source: org_study_id