Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors (ADRA)
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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 |
|---|
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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 |
- 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 ]
- 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 2013 |
| 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.
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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 |
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.
Contacts and Locations| United States, Arkansas | |
| Arkansas Children's Hospital Research Institute | |
| Little Rock, Arkansas, United States, 72202 | |
| Principal Investigator: | Tamara T. Perry, M.D. | University of Arkansas |
More Information
Publications:
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: | March 27, 2013 |
| 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:
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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 May 19, 2013