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Urban Environmental Factors and Childhood Asthma (URECA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114881
First Posted: June 20, 2005
Last Update Posted: January 11, 2017
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.
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  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 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.

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 ]
    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 ]
  • 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Additional Information:
Publications:
Gold DR, Bloomberg GR, Cruikshank WW, Visness CM, Schwarz J, Kattan M, O'Connor GT, Wood RA, Burger MS, Wright RJ, Witter F, Lee-Parritz A, Sperling R, Sadovsky Y, Togias A, Gern JE. Parental characteristics, somatic fetal growth, and season of birth influence innate and adaptive cord blood cytokine responses. J Allergy Clin Immunol. 2009 Nov;124(5):1078-87. doi: 10.1016/j.jaci.2009.08.021.
Zook PM, Jordan C, Adams B, Visness CM, Walter M, Pollenz K, Logan J, Tesson E, Smartt E, Chen A, D'Agostino J, Gern JE. Retention strategies and predictors of attrition in an urban pediatric asthma study. Clin Trials. 2010 Aug;7(4):400-10. doi: 10.1177/1740774510373798. Epub 2010 Jun 22.
Kakumanu S, Jaffee K, Visness CM, Dresen A, Burger M, Witter FR, O'Connor GT, Cruikshank WW, Shreffler WG, Bacharier LB, Gern JE. The influence of atopy and asthma on immune responses in inner-city adults. Immun Inflamm Dis. 2016 Feb 26;4(1):80-90. doi: 10.1002/iid3.96. eCollection 2016 Mar.
Gruenberg DA, Wright RJ, Visness CM, Jaffee KF, Bloomberg GR, Cruikshank WW, Kattan M, Sandel MT, Wood RA, Gern JE. Relation between stress and cytokine responses in inner-city mothers. Ann Allergy Asthma Immunol. 2015 Nov;115(5):439-445.e3. doi: 10.1016/j.anai.2015.07.021. Epub 2015 Sep 26.
McGowan EC, Bloomberg GR, Gergen PJ, Visness CM, Jaffee KF, Sandel M, O'Connor G, Kattan M, Gern J, Wood RA. Influence of early-life exposures on food sensitization and food allergy in an inner-city birth cohort. J Allergy Clin Immunol. 2015 Jan;135(1):171-8. doi: 10.1016/j.jaci.2014.06.033. Epub 2014 Aug 13.
Lynch SV, Wood RA, Boushey H, Bacharier LB, Bloomberg GR, Kattan M, O'Connor GT, Sandel MT, Calatroni A, Matsui E, Johnson CC, Lynn H, Visness CM, Jaffee KF, Gergen PJ, Gold DR, Wright RJ, Fujimura K, Rauch M, Busse WW, Gern JE. Effects of early-life exposure to allergens and bacteria on recurrent wheeze and atopy in urban children. J Allergy Clin Immunol. 2014 Sep;134(3):593-601.e12. doi: 10.1016/j.jaci.2014.04.018. Epub 2014 Jun 4.
Gern JE, Pappas T, Visness CM, Jaffee KF, Lemanske RF, Togias A, Bloomberg GR, Cruikshank WW, Lamm C, Tuzova M, Wood RA, Lee WM. Comparison of the etiology of viral respiratory illnesses in inner-city and suburban infants. J Infect Dis. 2012 Nov;206(9):1342-9. doi: 10.1093/infdis/jis504. Epub 2012 Sep 25.
Heymann PW, Platts-Mills TA. Deciphering the importance of host and environmental factors that influence the genesis of asthma during childhood. J Infect Dis. 2012 Nov;206(9):1331-3. doi: 10.1093/infdis/jis507. Epub 2012 Sep 25.
McLoughlin RM, Calatroni A, Visness CM, Wallace PK, Cruikshank WW, Tuzova M, Ly NP, Ruiz-Perez B, Kattan M, Bloomberg GR, Lederman H, Gern JE, Gold DR. Longitudinal relationship of early life immunomodulatory T cell phenotype and function to development of allergic sensitization in an urban cohort. Clin Exp Allergy. 2012 Mar;42(3):392-404. doi: 10.1111/j.1365-2222.2011.03882.x. Epub 2011 Nov 9.
Sumino K, Tucker J, Shahab M, Jaffee KF, Visness CM, Gern JE, Bloomberg GR, Holtzman MJ. Antiviral IFN-γ 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.
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.
Wood RA, Bloomberg GR, Kattan M, Conroy K, Sandel MT, Dresen A, Gergen PJ, Gold DR, Schwarz JC, Visness CM, Gern JE. Relationships among environmental exposures, cord blood cytokine responses, allergy, and wheeze at 1 year of age in an inner-city birth cohort (Urban Environment and Childhood Asthma study). J Allergy Clin Immunol. 2011 Apr;127(4):913-9.e1-6. doi: 10.1016/j.jaci.2010.12.1122. Epub 2011 Feb 18.
Gern JE. The Urban Environment and Childhood Asthma study. J Allergy Clin Immunol. 2010 Mar;125(3):545-9. doi: 10.1016/j.jaci.2010.01.037. Review.
Wright RJ, Visness CM, Calatroni A, Grayson MH, Gold DR, Sandel MT, Lee-Parritz A, Wood RA, Kattan M, Bloomberg GR, Burger M, Togias A, Witter FR, Sperling RS, Sadovsky Y, Gern JE. Prenatal maternal stress and cord blood innate and adaptive cytokine responses in an inner-city cohort. Am J Respir Crit Care Med. 2010 Jul 1;182(1):25-33. doi: 10.1164/rccm.200904-0637OC. Epub 2010 Mar 1.
Gern JE, Visness CM, Gergen PJ, Wood RA, Bloomberg GR, O'Connor GT, Kattan M, Sampson HA, Witter FR, Sandel MT, Shreffler WG, Wright RJ, Arbes SJ Jr, Busse WW. The Urban Environment and Childhood Asthma (URECA) birth cohort study: design, methods, and study population. BMC Pulm Med. 2009 May 8;9:17. doi: 10.1186/1471-2466-9-17.
Ly NP, Ruiz-Perez B, McLoughlin RM, Visness CM, Wallace PK, Cruikshank WW, Tzianabos AO, O'Connor GT, Gold DR, Gern JE. Characterization of regulatory T cells in urban newborns. Clin Mol Allergy. 2009 Jul 8;7:8. doi: 10.1186/1476-7961-7-8.
Shreffler WG, Visness CM, Burger M, Cruikshank WW, Lederman HM, de la Morena M, Grindle K, Calatroni A, Sampson HA, Gern JE. Standardization and performance evaluation of mononuclear cell cytokine secretion assays in a multicenter study. BMC Immunol. 2006 Dec 12;7:29.
Lee WM, Grindle K, Pappas T, Marshall DJ, Moser MJ, Beaty EL, Shult PA, Prudent JR, Gern JE. High-throughput, sensitive, and accurate multiplex PCR-microsphere flow cytometry system for large-scale comprehensive detection of respiratory viruses. J Clin Microbiol. 2007 Aug;45(8):2626-34. Epub 2007 May 30.
Lee WM, Kiesner C, Pappas T, Lee I, Grindle K, Jartti T, Jakiela B, Lemanske RF Jr, Shult PA, Gern JE. A diverse group of previously unrecognized human rhinoviruses are common causes of respiratory illnesses in infants. PLoS One. 2007 Oct 3;2(10):e966.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00114881     History of Changes
Other Study ID Numbers: DAIT ICAC-07
First Submitted: June 17, 2005
First Posted: June 20, 2005
Last Update Posted: January 11, 2017
Last Verified: January 2017

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


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