Allergic InflammationNCT01678222
The COX-2 Gene and the Immune System
An observational study of Allergic Inflammation and Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: The immune system contains several different types of cells in the blood and other parts of the body. The body can fight infections well with the right balance of these cell types. The wrong balance of cell types may cause diseases, such as allergies or asthma. Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Allergic Inflammation, Asthma
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2013to not given
- 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 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals who are homozygous for either the major or minor variant of both SNPs@@@
Who may be able to join
- Participant of the Environmental Polymorphisms Registry and current contact information available
- Genotype information available for relevant 765G>C and 8473T>C COX2 polymorphisms, which indicates:
- Individuals who are WT with respect to both 765G>C and 8473T>C (N=31)
- Individuals who are WT with respect to 765G>C and homozygous for 8473T>C (N=31)
- Individuals who are homozygous for both 765G>C and 8473T>C (N=31)
- Age 18- 65 years
Show all 9Show fewer
- Race self-identified as White or Black and Non-Hispanic ethnicity
- Willing and able to provide informed consent
- Able to comply with all protocol procedures
Who cannot join
- History of infection within the preceding 1 week or an oral temperature >38 degrees C
- Current daily or chronic use of corticosteroids (systemic, inhaled and topical).
- Any current conditions known to impact peripheral white blood cell count (e.g., leukemia, lymphopenia, AIDS, other immunodeficiency disorders)
- Current daily or chronic use of systemic immunosuppressants.
- Current pregnancy or lactation
- Unwilling or unable to:
Show all 14Show fewer
- Fast (including alcohol and caffeine-containing products) and discontinue tobacco use for 12 hours prior to the study visit
- Withhold all prescribed and over-the-counter medications and supplements the morning of the study visit, until after the visit is completed
- Refrain from taking the following medications and supplements for 7 days prior to the study visit:
- NSAIDs
- Corticosteroids (nasal, inhaled, topical or systemic)
- Fish oil and niacin supplements
- For blood draws that exceed 200ml, a hematocrit of <34% for women or <36% for men, or >56% for either gender.
- For blood draws exceeding 200ml, blood or plasma donation in the last 8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina
About this study
Official title: The Role of Functionally Relevant Cyclooxygenase-2 (COX-2) Gene Single Nucleotide Polymorphisms - 765G>C and 8473T>C in Lymphocyte Differentiation
Background:
- The immune system contains several different types of cells in the blood and other parts of the body. The body can fight infections well with the right balance of these cell types. The wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2 gene may help decide the balance of cell types that the body makes as part of the immune system. It may also play a role in certain immune system diseases. Researchers want to see how COX-2 affects the cells in the immune system.
Read more
Objectives:
- To study how the COX-2 gene works in the body s immune system.
Eligibility:
- Individuals 18 years of age and above who are part of the Environmental Polymorphisms Registry.
Design:
- Participants will have one study visit at the National Institutes of Health. They will collect a urine sample at home on the morning of the study visit.
- Participants will have a physical exam and medical history. They will provide a blood sample. They will also give researchers the urine sample they collected that morning.
- No treatment will be provided as part of this study.
Read the detailed description
This is a cross-sectional, controlled study designed to investigate the association of single nucleotide polymorphisms (SNPs) in the cyclooxygenase-2 (COX2) gene, also called prostaglandin endoperoxidase synthase 2 (PTGS2), on T-cell differentiation and function. Specifically, the impact of the promoter-region SNP 765G>C (rs20417) and the 3 untranslated region (UTR) SNP 8473T>C (rs5275) on T helper cell (Th) 2, Th9, and Th17 differentiation and function will be examined. Non-Hispanic, White or Black/African American, non-pregnant adults, aged 18-65 years, who are wild type (WT), with respect to both the 765G>C and 8473T>C SNPs, WT with respect to 765G>C and homozygous for 8473T>C, and homozygous for both 765G>C and 8473T>C will be recruited into a total of three genotype groups. Potential participants will be identified from the Environmental Polymorphisms Registry, contacted by recruitment letter and pre-screened for eligibility. Pre-screened individuals will provide verbal consent to withhold certadata analysis, a urine collection cup, and pre-visit instructions. Participants will attend a single study visit that will take place at the National Institute of Environmental Health Sciences (NIEHS) Clinical Research Unit (CRU). During this visit, written informed consent will be obtained, and there will be a final screening and eligibility determination, medical history review, vital signs, physical examination and blood and urine samples will be collected. From peripheral blood, lymphocyte subsets, prostaglandin levels, and cytokine levels will be determined; stable prostaglandin metabolites, creatinine, total protein and albumin will be measured in urine. Lymphocytes will be isolated from peripheral blood for ex vivo analyses. Demographic characteristics (i.e., age) will be compared between the groups, and when possible, recruitment will be targeted to achieve an approximate match of race and gender across the groups. The primary objective of the study is to determine whether the 765G>C or 8473T>C SNPs exhibit altered Th2, Th9 and Th17 cell differentiation by examining lymphocyte subsets in vivo. The study will also examine the impact of these two SNPs on circulating Th2/Th9/Th17 cytokine levels and prostaglandins in vivo, on differentiation of naive CD4+T-cells to Th cell subsets in vitro, and on lymphocyte production of cytokines and prostaglandins in vitro.
- Conditions
- Allergic Inflammation, Asthma
- Keywords
- Lymphocyte, Prostaglandin Endoperoxidase Synthase 2, COX-2, Natural History
- 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 |
|---|---|---|
| SNP | individuals who are homozygous for either the major or minor variant of both SNPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
Measured: Ongoing
To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start2 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allergic InflammationStudies 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
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Darryl C Zeldin, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678222
- Sponsor's protocol ID
- 120190
- Other IDs
- 12-E-0190
- Status last verified
- 28 Aug 2026
- First submitted
- 30 Aug 2012
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li H, Bradbury JA, Dackor RT, Edin ML, Graves JP, DeGraff LM, Wang PM, Bortner CD, Maruoka S, Lih FB, Cook DN, Tomer KB, Jetten AM, Zeldin DC. Cyclooxygenase-2 regulates Th17 cell differentiation during allergic lung inflammation. Am J Respir Crit Care Med. 2011 Jul 1;184(1):37-49. doi: 10.1164/rccm.201010-1637OC. Epub 2011 Apr 7.
PubMed 21474648McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci U S A. 1999 Jan 5;96(1):272-7. doi: 10.1073/pnas.96.1.272.
PubMed 9874808Mai J, Wang H, Yang XF. Th 17 cells interplay with Foxp3+ Tregs in regulation of inflammation and autoimmunity. Front Biosci (Landmark Ed). 2010 Jun 1;15(3):986-1006. doi: 10.2741/3657.
PubMed 20515737
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Functionally Relevant Cyclooxygenase-2 (COX-2) Gene Single Nucleotide Polymorphisms - 765G>C and 8473T>C in Lymphocyte Differentiation
- ClinicalTrials.gov ID
- NCT01678222
- Acronym / sponsor ID
- 120190
- Conditions
- Allergic Inflammation, Asthma
- Keywords
- Lymphocyte, Prostaglandin Endoperoxidase Synthase 2, COX-2, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 2 May 2013 (actual)
- First posted
- 3 Sep 2012 (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.
Background:
- The immune system contains several different types of cells in the blood and other parts of the body. The body can fight infections well with the right balance of these cell types. The wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2 gene may help decide the balance of cell types that the body makes as part of the immune system. It may also play a role in certain immune system diseases. Researchers want to see how COX-2 affects the cells in the immune system.
Objectives:
- To study how the COX-2 gene works in the body s immune system.
Eligibility:
- Individuals 18 years of age and above who are part of the Environmental Polymorphisms Registry.
Design:
- Participants will have one study visit at the National Institutes of Health. They will collect a urine sample at home on the morning of the study visit.
- Participants will have a physical exam and medical history. They will provide a blood sample. They will also give researchers the urine sample they collected that morning.
- No treatment will be provided as part of this study.
Detailed description
This is a cross-sectional, controlled study designed to investigate the association of single nucleotide polymorphisms (SNPs) in the cyclooxygenase-2 (COX2) gene, also called prostaglandin endoperoxidase synthase 2 (PTGS2), on T-cell differentiation and function. Specifically, the impact of the promoter-region SNP 765G>C (rs20417) and the 3 untranslated region (UTR) SNP 8473T>C (rs5275) on T helper cell (Th) 2, Th9, and Th17 differentiation and function will be examined. Non-Hispanic, White or Black/African American, non-pregnant adults, aged 18-65 years, who are wild type (WT), with respect to both the 765G>C and 8473T>C SNPs, WT with respect to 765G>C and homozygous for 8473T>C, and homozygous for both 765G>C and 8473T>C will be recruited into a total of three genotype groups. Potential participants will be identified from the Environmental Polymorphisms Registry, contacted by recruitment letter and pre-screened for eligibility. Pre-screened individuals will provide verbal consent to withhold certadata analysis, a urine collection cup, and pre-visit instructions. Participants will attend a single study visit that will take place at the National Institute of Environmental Health Sciences (NIEHS) Clinical Research Unit (CRU). During this visit, written informed consent will be obtained, and there will be a final screening and eligibility determination, medical history review, vital signs, physical examination and blood and urine samples will be collected. From peripheral blood, lymphocyte subsets, prostaglandin levels, and cytokine levels will be determined; stable prostaglandin metabolites, creatinine, total protein and albumin will be measured in urine. Lymphocytes will be isolated from peripheral blood for ex vivo analyses. Demographic characteristics (i.e., age) will be compared between the groups, and when possible, recruitment will be targeted to achieve an approximate match of race and gender across the groups. The primary objective of the study is to determine whether the 765G>C or 8473T>C SNPs exhibit altered Th2, Th9 and Th17 cell differentiation by examining lymphocyte subsets in vivo. The study will also examine the impact of these two SNPs on circulating Th2/Th9/Th17 cytokine levels and prostaglandins in vivo, on differentiation of naive CD4+T-cells to Th cell subsets in vitro, and on lymphocyte production of cytokines and prostaglandins in vitro.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNP | – | –individuals who are homozygous for either the major or minor variant of both SNPs |
Who may qualify
- Ages
- 18 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals who are homozygous for either the major or minor variant of both SNPs@@@
Key inclusion criteria (9 listed)
- Participant of the Environmental Polymorphisms Registry and current contact information available
- Genotype information available for relevant 765G>C and 8473T>C COX2 polymorphisms, which indicates:
- Age 18- 65 years
- Race self-identified as White or Black and Non-Hispanic ethnicity
- Willing and able to provide informed consent
Key exclusion criteria (14 listed)
- History of infection within the preceding 1 week or an oral temperature >38 degrees C
- Current daily or chronic use of corticosteroids (systemic, inhaled and topical).
- Any current conditions known to impact peripheral white blood cell count (e.g., leukemia, lymphopenia, AIDS, other immunodeficiency disorders)
- Current daily or chronic use of systemic immunosuppressants.
- Current pregnancy or lactation
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
To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
Time frame: Ongoing
To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
Time frame: Ongoing
To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
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 16 Oct 2026.
- Background: PubMed 21474648Li H, Bradbury JA, Dackor RT, Edin ML, Graves JP, DeGraff LM, Wang PM, Bortner CD, Maruoka S, Lih FB, Cook DN, Tomer KB, Jetten AM, Zeldin DC. Cyclooxygenase-2 regulates Th17 cell differentiation during allergic lung inflammation. Am J Respir Crit Care Med. 2011 Jul 1;184(1):37-49. doi: 10.1164/rccm.201010-1637OC. Epub 2011 Apr 7.
- Background: PubMed 9874808McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci U S A. 1999 Jan 5;96(1):272-7. doi: 10.1073/pnas.96.1.272.
- Background: PubMed 20515737Mai J, Wang H, Yang XF. Th 17 cells interplay with Foxp3+ Tregs in regulation of inflammation and autoimmunity. Front Biosci (Landmark Ed). 2010 Jun 1;15(3):986-1006. doi: 10.2741/3657.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Darryl C Zeldin, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
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 Allergic Inflammation 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 9 inclusion and 14 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 16 Oct 2026. 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?
To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo (time frame: Ongoing). The study lists 2 primary outcomes in all. 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 NCT01678222, which also lists 3 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 16 Oct 2026.