Expired Study
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Little Rock, Arkansas 72202


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

53054


NCT ID:

NCT00590304


Secondary ID:


Study Acronym:

ADRA


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

4 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Arkansas Children's Hospital Research Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

116


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:October 2006
Completion Date:July 2015
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 11, 2017
First Received Date:December 27, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The study will yield preliminary and feasibility data critical for designing future large-scale asthma studies among high-risk populations.
Time Frame:Three years
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:EU, LV, MA, EL, DU
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Arkansas Children's Hospital Research Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:Robert Wood Johnson Foundation

Samples and Retentions

Sample Retention:Samples With DNA
Description: 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.
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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation: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.
Reference Type:Reference
Citation:Perry TT, Vargas PA, McCracken A, Jones SM. Underdiagnosed and uncontrolled asthma: findings in rural schoolchildren from the Delta region of Arkansas. Ann Allergy Asthma Immunol. 2008 Oct;101(4):375-81. doi: 10.1016/S1081-1206(10)60313-4.
PMID:18939725

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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