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Urban Environmental Factors and Childhood Asthma (URECA)

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: June 1, 2016
Last verified: June 2016
  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.
  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.

Condition
Asthma
Allergy

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

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

  • Incidence of Asthma [ Time Frame: up to 16 years of age ] [ Designated as safety issue: No ]
  • Occurrence of Specific Phenotypes of Asthma [ Time Frame: up to 16 years of age ] [ Designated as safety issue: No ]
    Further define asthma phenotypes based on the findings in 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

Enrollment: 609
Study Start Date: January 2005
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Inner-City Asthma Consortium
Investigators
Principal Investigator: Leonard B. Bacharier, MD Department of Pediatrics, Washington University and St Louis Children's Hospital
Principal Investigator: Meyer Kattan, MD, CM Pediatric Pulmonary Division, Columbia University Medical Center
Principal Investigator: George T. O'Connor, MD, MS Division of Pulmonary, Allergy, Sleep, and Critical Care Medicine, Boston University School of Medicine
Principal Investigator: Robert A. Wood, MD Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine
  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: June 1, 2016
Health Authority: United States: Federal Government
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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 December 07, 2016