Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors (ADRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00590304
First received: December 27, 2007
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to evaluate asthma and examine the homes of children with asthma living in rural areas of the state. This study is being done to give investigators more information about the presence of allergens and endotoxin in the homes of children with asthma living in the delta region of Arkansas.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Asthma morbidity data will be analyzed to examine relationships between home environment factors and morbidity outcomes such as symptom frequency, medication use, healthcare utilizations and decreased activity. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The study will yield preliminary and feasibility data critical for designing future large-scale asthma studies among high-risk populations. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Optional buccal swab samples will be obtained from participants. This is done by touching the inside of the participant's cheek to collect a sample of the cells in his/her mouth with a cotton swab type applicator.


Enrollment: 116
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
EU, LV, MA, EL, DU
The population will consist of 120 English-speaking participants ages 4-17 years from four rural schools with physician-diagnosed asthma or symptoms of asthma in the previous 12 months. As of June 2008, an additional rural school has been added to the population criteria, making a total of five rural schools.

Detailed Description:

Asthma is the most common chronic disease of children and disproportionately affects minority and low-income children. Current pediatric asthma research in this high-risk group focuses on children living in inner-city environments. Low-income, minority children with asthma from non-urban locales have not been studied extensively. The specific aims of the study will examine the impact of home environmental exposure to endotoxin on asthma severity and atopy status in the rural setting among predominately African American, low-income asthmatics. This study will answer several research questions. The first question involves the relationship between asthma severity and exposure to endotoxin among rural children at high risk for increased morbidity and mortality. Second, the relationship between atopy and endotoxin exposure has been the subject of recent debates among asthma researchers. The hygiene hypothesis suggest that the recent rise in atopic disease in Westernized societies is due to decreased microbial burden. Last data on atopy and aeroallergen exposure among high-risk rural asthmatics will be critical in the design and implementation of future intervention programs.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be children with asthma, ages 4-17 years from the Mississippi Delta region. The Mississippi Delta has been identified as one of the poorest, medically-underserved regions of the United States, and includes the geographic regions of Arkansas, Louisiana and Mississippi that are contiguous with the Mississippi River. Participants for the study will be recruited from Eudora, Lake Village, Marvell and Elaine public school districts. Since June 2008, the Dumas Public School District has been added in the recruitment. These districts are located in the Delta region of Arkansas where more than one-third of families with children 5-17 years are below the 2000 poverty line (Census bureau). Students in these school districts are predominately of a miniority population.

Criteria

Inclusion Criteria:

  • English speaking participants aged 4-17 years from four rural schools with physician diagnosed asthma or symptoms of asthma in the previous 12 months (coughing, wheezing, chest tightness, shortness of breath) (per parental or legal guardian report) and current taking prescribed medications for asthma such as inhalers, syrup or breathing machine.

Exclusion Criteria:

  • Children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions such as severe developmental delay or cerebral palsy will be excluded from the study.
  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: NCT00590304

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Tamara T. Perry, M.D. University of Arkansas
  More Information

Publications:
Perry TT, Vargas PA, Brown R, Watkins D, McCracken A, Jones S. Asthma morbidity in high risk rural children in the delta region of Arkansas. J Allergy Clin Immunol 2008;121:S231.
Pesek R, PA V, Jones S, McCracken A, Perry TT. Pediatric asthma diagnosis and morbidity in urban and rural Arkansas. J Allergy Clin Immunol 2009;123:S210.
Haynes A, Vargas PA, Watkins D, Brown R, McCracken A, Jones S. Allergen exposure and home characteristics of high risk rural children with asthma. J Allergy Clin Immunol 2008;121:S231.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00590304     History of Changes
Other Study ID Numbers: 53054
Study First Received: December 27, 2007
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Asthma, Children, Rural Population, Morbidity, Endotoxin

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 August 01, 2014