Nitric Oxide, LPS and the Pathogenesis of Asthma Phase 1
2 other identifiers
observational
420
1 country
1
Brief Summary
The purpose of the study is to determine the role of nitric oxide (NO) in asthma. We determine the effect of promoter polymorphisms in the gene for the NO producing enzyme, nitric oxide synthase (NOS2), on exhaled NO in healthy African Americans and Caucasians. We compare exhaled NO levels between African Americans and Caucasians. Information on race or ethnicity, serum samples, blood pressure, exhaled breath condensate and health questionnaires will be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedApril 14, 2015
April 1, 2015
5.1 years
May 2, 2008
April 13, 2015
Conditions
Keywords
Study Arms (2)
1
African American
2
Caucasian
Eligibility Criteria
Community sample
You may qualify if:
- Willing/able to give informed consent
- self declared non-atopic, non-asthmatic
- never cigarette smoker,
- no significant occupational exposure to respiratory irritants or toxins,
- no chronic illness
- no chronic use of medications (excluding contraceptive medication),
- no historical unstable cardiac or severe lung disease,
- within study age parameters of 18 - 40
You may not qualify if:
- occupational exposure to hay or grain
- smoked 20 or more packs of cigarettes in a lifetime.
- prior allergen immunotherapy
- Allergy and or asthma
- Students or employees under direct supervision by protocol investigators are ineligible
- Nursing mothers
- pregnancy
- Other investigational medication within the last 30 days
- Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Levesque MC, Hauswirth DW, Mervin-Blake S, Fernandez CA, Patch KB, Alexander KM, Allgood S, McNair PD, Allen AS, Sundy JS. Determinants of exhaled nitric oxide levels in healthy, nonsmoking African American adults. J Allergy Clin Immunol. 2008 Feb;121(2):396-402.e3. doi: 10.1016/j.jaci.2007.09.031. Epub 2007 Nov 26.
PMID: 18036642RESULT
Biospecimen
Serum samples, DNA, Exhaled Breah Condensate
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc C Levesque, M.D., PhD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 5, 2008
Study Start
May 1, 2003
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
April 14, 2015
Record last verified: 2015-04