NCT00671229

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

5.1 years

First QC Date

May 2, 2008

Last Update Submit

April 13, 2015

Conditions

Keywords

HealthyAsthmaNitric Oxide

Study Arms (2)

1

African American

2

Caucasian

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples, DNA, Exhaled Breah Condensate

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Marc C Levesque, M.D., PhD

    Duke University

    PRINCIPAL INVESTIGATOR

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

Locations