AsthmaADRANCT00590304
Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors
An observational study of Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Asthma
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
About this study
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.
Read the 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.
- Conditions
- Asthma
- Keywords
- Asthma, Children, Rural Population, Morbidity, Endotoxin
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2009
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Tamara T. Perry, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590304
- Sponsor's protocol ID
- 53054
- Acronym
- ADRA
- Status last verified
- Sep 2017
- First submitted
- 27 Dec 2007
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share individual data.
Publications
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.
PubMed 18939725Pesek 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.
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.
Coleman AT, Rettiganti M, Bai S, Brown RH, Perry TT. Mouse and cockroach exposure in rural Arkansas Delta region homes. Ann Allergy Asthma Immunol. 2014 Mar;112(3):256-60. doi: 10.1016/j.anai.2014.01.002. Epub 2014 Jan 31.
PubMed 24491312Perry TT, Rettiganti M, Brown RH, Nick TG, Jones SM. Uncontrolled asthma and factors related to morbidity in an impoverished, rural environment. Ann Allergy Asthma Immunol. 2012 Apr;108(4):254-9. doi: 10.1016/j.anai.2012.01.017. Epub 2012 Feb 15.
PubMed 22469445
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors
- ClinicalTrials.gov ID
- NCT00590304
- Acronym / sponsor ID
- ADRA / 53054
- Conditions
- Asthma
- Keywords
- Asthma, Children, Rural Population, Morbidity, Endotoxin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Oct 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The study will yield preliminary and feasibility data critical for designing future large-scale asthma studies among high-risk populations.
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 18939725Perry 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.
- Results publicationPesek 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.
- Results publicationHaynes 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.
- Derived from this study: PubMed 24491312Coleman AT, Rettiganti M, Bai S, Brown RH, Perry TT. Mouse and cockroach exposure in rural Arkansas Delta region homes. Ann Allergy Asthma Immunol. 2014 Mar;112(3):256-60. doi: 10.1016/j.anai.2014.01.002. Epub 2014 Jan 31.
- Derived from this study: PubMed 22469445Perry TT, Rettiganti M, Brown RH, Nick TG, Jones SM. Uncontrolled asthma and factors related to morbidity in an impoverished, rural environment. Ann Allergy Asthma Immunol. 2012 Apr;108(4):254-9. doi: 10.1016/j.anai.2012.01.017. Epub 2012 Feb 15.
- Individual participant dataSharing planned: No. There is no plan to share individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara T. Perry, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590304, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.