Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02743468
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2016-04-14
Brief Title:
Cytochrome P450 Epoxygenase Pathway Regulation of Macrophage Function
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytochrome P450 Epoxygenase Pathway Regulation of Macrophage Function
Status:
COMPLETED
Status Verified Date:
2024-07-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 eg 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-E-0096 | None | None | None |