Nitric Oxide, LPS and the Pathogenesis of Asthma Phase 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute of Environmental Health Sciences (NIEHS).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sandler Program for Asthma Research
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00671229
First received: May 2, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition
Healthy
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nitric Oxide, LPS and the Pathogenesis of Asthma Phase 1

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Biospecimen Retention:   Samples With DNA

Serum samples, DNA, Exhaled Breah Condensate


Estimated Enrollment: 1600
Study Start Date: May 2003
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
African American
2
Caucasian

Detailed Description:

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.

Three single nucleotide polymorphisms (SNPs) have been identified in Africans that are associated with increases in systemic NO production. These studies determine whether the NOS2 promoter SNPs are associated with differences in basal exhaled NO levels. The study of exhaled NO levels in individuals with asthma is confounded by the presence of cell types besides bronchial epithelium that produce NO, by differences in the severity of asthma and by the use of medications such as corticosteroids which alter exhaled NO levels.

Therefore, in this study exhaled NO levels in asymptomatic healthy African Americans and Caucasians are measured. The initial analysis of exhaled NO levels indicate that a subset of African American samples contained lower levels of NO than previous measurements of exhaled NO levels in Caucasians. Because differences in exhaled NO levels may influence bronchodilation and other airway responses, as part of this study, the exhaled NO levels of the African American subjects are compared to the results of sample collections from Caucasian samples.

In addition to measures of exhaled NO levels, information on race or ethnicity and DNA samples are collected to characterize samples collected from African American and Caucasian subjects. Serum samples, measures of blood pressure and exhaled breath condensate samples are collected from African Americans and Caucasians to control for confounding variables. Repeated measures of exhaled NO levels are collected to control for fluctuations in exhaled NO levels related to upper respiratory infections.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671229

Contacts
Contact: Catherine M Foss, B.S. (919)668-3599 foss0005@mc.duke.edu
Contact: Marc C Levesque, M.D., PhD (919) 613-7931 marc.levesque@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Catherine M Foss, B.S.    919-668-3599    foss0005@mc.duke.edu   
Contact: John S Sundy, M.D., PhD.    (919) 668-2169    john.sundy@duke.edu   
Sub-Investigator: John S Sundy, M.D., PhD         
Sponsors and Collaborators
Sandler Program for Asthma Research
Investigators
Principal Investigator: Marc C Levesque, M.D., PhD Duke University
  More Information

Publications:
Responsible Party: Marc C. Levesque, NIEHS
ClinicalTrials.gov Identifier: NCT00671229     History of Changes
Other Study ID Numbers: 12496-CP-006A, Pro00005046
Study First Received: May 2, 2008
Last Updated: May 2, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Healthy
Asthma
Nitric Oxide

Additional relevant MeSH terms:
Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014