Urban Environmental Factors and Childhood Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00114881
First received: June 17, 2005
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 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 [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:


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 (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


Biospecimen Retention:   Samples With DNA
  • Sample of umbilical cord blood (mother)
  • Maternal blood sample
  • 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
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:
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: April 7, 2014
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 April 17, 2014