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

Asthma Clinical Trial

— ADRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590304
• Other study ID #: 53054
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: September 11, 2017
• Start date: October 2006
• Est. completion date: July 2015

Study information

• Verified date: September 2017
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2015
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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.

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.

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Three years
Secondary	The study will yield preliminary and feasibility data critical for designing future large-scale asthma studies among high-risk populations.		Three years