PolymorphismNCT02743468
Cytochrome P450 Epoxygenase Pathway Regulation of Macrophage Function
An observational study of Polymorphism and Lung Inflammation, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: Respiratory diseases affect more than 1 billion people worldwide. They are a growing public health concern. The lungs are constantly exposed to environmental factors such as dust, fumes, microbes, and pollutants. But much is still not known about how these pollutants lead to respiratory illnesses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Polymorphism, Lung Inflammation
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 21 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Age 18 to 65 years, inclusive (males and females)
- Able to travel to the NIEHS CRU for required study visits
- Able to present a valid government-issued form of identification for entry to the NIEHS campus
- Able to fast for 8 hours prior to the visit where bronchoscopy occurs
- Has a responsible party who is willing and able to attend Visit 2 and drive the participant away from the CRU after completion of Visit 2, if the participant elects to undergo conscious sedation
- Genotype information available for relevant CYP2J2 and EPHX2 polymorphisms, which indicates:
Show all 10Show fewer
- Wild type with respect to EPHX2 K55R, EPHX2 R287Q, and CYP2J2*7; or
- Homozygous for EPHX2 K55R (wild type for the other SNPs); or
- Homozygous for EPHX2 R287Q (wild type for the other SNPs); or
- Homozygous for CYP2J2*7 (wild type for the other SNPs)
Who cannot join
- Current pregnancy or lactation, as medications used during the bronchoscopy can be excreted in the breast milk of lactating mothers
- Current smoker or significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening)
- Post-bronchodilator FEV1 < 70% of predicted
- For asthmatics, any indication of moderate or severe asthma such as:
- Physician-directed emergency treatment for an asthma exacerbation within the preceding 12 months
- Any use of systemic steroid therapy during the last year or continuous use of inhaled steroids over a period of 1 month or longer during the past 6 months
Show all 33Show fewer
- Regular use of cromolyn (except for prophylaxis of exercise induced bronchospasm) or any use of leukotriene inhibitors (Montelukast or Zafirlukast) within the past month
- Symptoms including:
- Night-time symptoms of cough or wheeze greater than 1x/week
- Exacerbations of asthma more than 2x/week
- Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness)
- Bleeding disorders or regular use of aspirin or other non-steroidal anti-inflammatory drugs (which inhibit platelet function) or other drugs that prolong bleeding time such as warfarin, heparin or derivatives, or clopidogrel and related ADP inhibitors
- Sickle cell disease or GP6 deficiency
- Facial deformity or major facial surgery
- Asthma exacerbation or respiratory infection 4 weeks prior to study visit
- Allergy or history of adverse reactions to lidocaine, midazolam, or fentanyl
- Vital signs (temperature, blood pressure, pulse rate) that are outside of the established CRU limits
- Body weight <50 kg (<110 lbs)
- The following abnormal clinical laboratory values (obtained during Visit 1 assessment):
- Platelet count <100,000 per L
- White blood cells count <3000 per L
- Absolute neutrophil count <1000 per L
- Hematocrit <35% for both female and male
- PT/INR and PTT based on reference laboratory established reference ranges
- Serum creatinine >1.4 mg/dL
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.
- Use of the medication colchicine (commonly used to treat gout attacks) in the past 2 weeks.
- Volunteers meeting any of the below temporary exclusions may enroll in the study, but may not
- undergo the bronchoscopy procedure within the time frames specified for each below temporary exclusion. If any of the following conditions are met, the bronchoscopy will be rescheduled such that none of these temporary exclusions apply:
- Temp. EXCL 1. An asthma exacerbation requiring increased asthma medications for more than 1 day (and other than exercise-induced asthma) within 1 month of bronchoscopy
- Temp. EXCL 2. Viral upper respiratory tract infection or any acute infection requiring antibiotics within 4 weeks of bronchoscopy
- Temp. EXCL 3. Use of anti-inflammatory medications (including over-the-counter preparations) during the 48 hours prior to the bronchoscopy and aspirin during the 14 days prior to bronchoscopy.
- Temp. EXCL 4. Any food or fluids for 8 hours prior to the bronchoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Background:
Respiratory diseases affect more than 1 billion people worldwide. They are a growing public health concern. The lungs are constantly exposed to environmental factors such as dust, fumes, microbes, and pollutants. But much is still not known about how these pollutants lead to respiratory illnesses. Researchers want to collect samples from lungs and blood to see how genetics and environmental pollutants affect cellular responses or functioning.
Read more
Objectives:
To study how cytochrome P450 epoxygenase pathway enzymes affect macrophage function in the lungs and inflammatory responses.
Eligibility:
Adults ages 18 65 who can have a bronchoscopy.
Design:
All study visits will take place at the NIEHS Clinical Research Unit in Research Triangle Park, NC.
At study visit 1, participants will be screened with medical history and physical exam. They will have blood and urine tests. They will take tests that measure their lung function. They will answer questionnaires. Before the visit, they will be given a list of medicines they cannot take. They also must not have caffeine on the day of their visit. The visit will last about 3 hours.
At study visit 2, participants will give blood samples. They will undergo bronchoscopy. For this, they will get an intravenous line in a vein to get sedatives. Their airways will be numbed. Cells will be collected from their lungs. They will fast for 8 hours before the visit. They must have someone else drive them home from the visit. The visit will last about 3-4 hours.
Participants will get a follow-up phone call about 1 day after study visit 2.
Read the detailed description
This is a prospective, cross-sectional study designed to provide a consistent method for obtaining biological samples and respiratory health-related information from participants for use in research that evaluates lung function (e.g., responses to environmental agents such as air pollution particles, engineered nanomaterials, or immune ligands; the role of genetics on cellular responses or functioning).
Study participants will be adult volunteers, ages 18-65 (inclusive), who meet eligibility criteria to undergo bronchoscopy. Potential participants will be prescreened and scheduled for a final eligibility visit that will include medical history review, vital signs, physical examination, blood draw, and pulmonary function tests. After eligibility is confirmed, the participant will be scheduled for biological sample collections, which will include a blood draw and bronchoscopy.
The objective of this protocol is to investigate the role of cytochrome P450 (CYP) epoxygenase pathway enzymes, including the soluble epoxide hydrolase (sEH; encoded by EPHX2) and CYP2J2 proteins, in macrophage function and inflammatory responses. The primary outcome measure will evaluate macrophage phagocytosis in an ex vivo assay, comparing groups of individuals with and without EPHX2 and CYP2J2 polymorphisms of interest. Secondary outcomes will include evaluations of ex vivo gene expression of inflammatory receptors and cytokines in stimulated macrophages (alveolar and peripheral blood monocyte-derived), assessment of the lower airway microbiome from bronchoalveolar lavage (BAL) fluid, and measurement of eicosanoids and cytokines in serum and BAL fluid.
- Conditions
- Polymorphism, Lung Inflammation
- Keywords
- Bronchoscopy, Pollutants, Human Pulmonary Cells, Macrophage Function, Soluble Epoxide Hydrolase, Natural History
- Medical subject headings
- Pneumonia
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 |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will evaluate macrophage phagocytosis of fluorescein isothiocyanate (FITC)-labeled beads and bacteria (Streptococcus pneumoniae) in an ex vivo assay, comparing alveolar macrophages from groups of individuals with and ...
The primary outcome measure will evaluate macrophage phagocytosis of fluorescein isothiocyanate (FITC)-labeled beads and bacteria (Streptococcus pneumoniae) in an ex vivo assay, comparing alveolar macrophages from groups of individuals with and without EPHX2 and CYP2J2 polymorphisms of interest.
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start8 Jan 2019
- Primary completion18 Dec 2019
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymorphismStudies 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
- 20 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
- NCT02743468
- Sponsor's protocol ID
- 160096
- Other IDs
- 16-E-0096
- Status last verified
- 3 Apr 2026
- First submitted
- 14 Apr 2016
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It isn t known yet if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytochrome P450 Epoxygenase Pathway Regulation of Macrophage Function
- ClinicalTrials.gov ID
- NCT02743468
- Acronym / sponsor ID
- 160096
- Conditions
- Polymorphism, Lung Inflammation
- Keywords
- Bronchoscopy, Pollutants, Human Pulmonary Cells, Macrophage Function, Soluble Epoxide Hydrolase, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 19 Apr 2016 (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:
Respiratory diseases affect more than 1 billion people worldwide. They are a growing public health concern. The lungs are constantly exposed to environmental factors such as dust, fumes, microbes, and pollutants. But much is still not known about how these pollutants lead to respiratory illnesses. Researchers want to collect samples from lungs and blood to see how genetics and environmental pollutants affect cellular responses or functioning.
Objectives:
To study how cytochrome P450 epoxygenase pathway enzymes affect macrophage function in the lungs and inflammatory responses.
Eligibility:
Adults ages 18 65 who can have a bronchoscopy.
Design:
All study visits will take place at the NIEHS Clinical Research Unit in Research Triangle Park, NC.
At study visit 1, participants will be screened with medical history and physical exam. They will have blood and urine tests. They will take tests that measure their lung function. They will answer questionnaires. Before the visit, they will be given a list of medicines they cannot take. They also must not have caffeine on the day of their visit. The visit will last about 3 hours.
At study visit 2, participants will give blood samples. They will undergo bronchoscopy. For this, they will get an intravenous line in a vein to get sedatives. Their airways will be numbed. Cells will be collected from their lungs. They will fast for 8 hours before the visit. They must have someone else drive them home from the visit. The visit will last about 3-4 hours.
Participants will get a follow-up phone call about 1 day after study visit 2.
Detailed description
This is a prospective, cross-sectional study designed to provide a consistent method for obtaining biological samples and respiratory health-related information from participants for use in research that evaluates lung function (e.g., responses to environmental agents such as air pollution particles, engineered nanomaterials, or immune ligands; the role of genetics on cellular responses or functioning).
Study participants will be adult volunteers, ages 18-65 (inclusive), who meet eligibility criteria to undergo bronchoscopy. Potential participants will be prescreened and scheduled for a final eligibility visit that will include medical history review, vital signs, physical examination, blood draw, and pulmonary function tests. After eligibility is confirmed, the participant will be scheduled for biological sample collections, which will include a blood draw and bronchoscopy.
The objective of this protocol is to investigate the role of cytochrome P450 (CYP) epoxygenase pathway enzymes, including the soluble epoxide hydrolase (sEH; encoded by EPHX2) and CYP2J2 proteins, in macrophage function and inflammatory responses. The primary outcome measure will evaluate macrophage phagocytosis in an ex vivo assay, comparing groups of individuals with and without EPHX2 and CYP2J2 polymorphisms of interest. Secondary outcomes will include evaluations of ex vivo gene expression of inflammatory receptors and cytokines in stimulated macrophages (alveolar and peripheral blood monocyte-derived), assessment of the lower airway microbiome from bronchoalveolar lavage (BAL) fluid, and measurement of eicosanoids and cytokines in serum and BAL fluid.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (10 listed)
- Wild type with respect to EPHX2 K55R, EPHX2 R287Q, and CYP2J2*7; or
- Homozygous for EPHX2 K55R (wild type for the other SNPs); or
- Homozygous for EPHX2 R287Q (wild type for the other SNPs); or
- Homozygous for CYP2J2*7 (wild type for the other SNPs)
Key exclusion criteria (33 listed)
- Current pregnancy or lactation, as medications used during the bronchoscopy can be excreted in the breast milk of lactating mothers
- Current smoker or significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening)
- Post-bronchodilator FEV1 < 70% of predicted
- For asthmatics, any indication of moderate or severe asthma such as:
- Bleeding disorders or regular use of aspirin or other non-steroidal anti-inflammatory drugs (which inhibit platelet function) or other drugs that prolong bleeding time such as warfarin, heparin or derivatives, or clopidogrel and related ADP inhibitors
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
The primary outcome measure will evaluate macrophage phagocytosis of fluorescein isothiocyanate (FITC)-labeled beads and bacteria (Streptococcus pneumoniae) in an ex vivo assay, comparing alveolar macrophages from groups of individuals with and ...
Time frame: Cross-sectional
The primary outcome measure will evaluate macrophage phagocytosis of fluorescein isothiocyanate (FITC)-labeled beads and bacteria (Streptococcus pneumoniae) in an ex vivo assay, comparing alveolar macrophages from groups of individuals with and without EPHX2 and CYP2J2 polymorphisms of interest.
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 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It isn t known yet if there will be a plan to make IPD available
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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 Polymorphism and Lung Inflammation, 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 10 inclusion and 33 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 29 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?
The primary outcome measure will evaluate macrophage phagocytosis of fluorescein isothiocyanate (FITC)-labeled beads and bacteria (Streptococcus pneumoniae) in an ex vivo assay, comparing alveolar macrophages from groups of individuals with and ... (time frame: Cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.