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Completed

NCT Number: NCT00590304

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

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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Acronym: ADRA

Important dates

Study start
2006
Primary completion
2009
Study completion
2015
First posted
Jan 10, 2008
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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