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

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ClinicalTrials.gov Identifier: NCT00590304
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : September 12, 2017
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:
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 or disease

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.

Study Type : Observational
Actual Enrollment : 116 participants
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
Study Start Date : October 2006
Primary Completion Date : December 2009
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The study will yield preliminary and feasibility data critical for designing future large-scale asthma studies among high-risk populations. [ Time Frame: Three years ]

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

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.

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): NCT00590304

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
Principal Investigator: Tamara T. Perry, M.D. University of Arkansas

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.

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
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual data.

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases