HealthyNCT00671229
Nitric Oxide, LPS and the Pathogenesis of Asthma Phase 1
An observational study of Healthy and Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jun 2008
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Keywords
- Healthy, Asthma, Nitric Oxide
- 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 |
|---|---|---|
| 1 | African American | |
| 2 | Caucasian |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startMay 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Sandler Program for Asthma Research
- Investigators
- Marc C Levesque, M.D., PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671229
- Sponsor's protocol ID
- 12496-CP-006A
- Other IDs
- Pro00005046
- Status last verified
- Apr 2015
- First submitted
- 2 May 2008
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18036642
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide, LPS and the Pathogenesis of Asthma Phase 1
- ClinicalTrials.gov ID
- NCT00671229
- Acronym / sponsor ID
- 12496-CP-006A
- Keywords
- Healthy, Asthma, Nitric Oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- Sandler Program for Asthma Research
- Study start
- May 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 May 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –African American |
| 2 | – | –Caucasian |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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
Not reported in the source record.
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 14 Apr 2015.
- Results publication: PubMed 18036642Levesque 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Marc C Levesque, M.D., PhD principal investigator
Duke University
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 Healthy and Asthma, run by National Institute of Environmental Health Sciences (NIEHS) 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 8 inclusion and 9 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 14 Apr 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671229, which also lists 1 linked publication.
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 14 Apr 2015.