The COX-2 Gene and the Immune System

NCT01678222 | Completed

• 2 other identifiers: 12019012-E-0190
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Inflammation; Asthma

Keywords

Lymphocyte; Prostaglandin Endoperoxidase Synthase 2; COX-2; Natural History

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Ongoing

Study Arms (1)

SNP

individuals who are homozygous for either the major or minor variant of both SNPs

Eligibility Criteria

• Age: 18 Years - 150 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

individuals who are homozygous for either the major or minor variant of both SNPs@@@

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

Location

Related Publications (3)

• 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.

  PMID: 21474648 BACKGROUND

• McAdam 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.

  PMID: 9874808 BACKGROUND

• Mai 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.

  PMID: 20515737 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Darryl C Zeldin, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: May 2, 2013
• Last Updated: April 20, 2026

Record last verified: 2025-09-18

Locations

US (1)