This trial has been completed.

Condition asthma
Sponsor Arkansas Children's Hospital Research Institute
Collaborator Robert Wood Johnson Foundation
Start date October 2006
End date December 2009
Trial size 116 participants
Trial identifier NCT00590304, 53054


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective cross-sectional
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 Outcomes

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 Outcomes

The study will yield preliminary and feasibility data critical for designing future large-scale asthma studies among high-risk populations.
time frame: Three years

Eligibility Criteria

Male or female participants from 4 years up to 17 years old.

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.

Additional Information

Official title Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors
Principal investigator Tamara T. Perry, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute.