Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02767973
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2016-05-03
Brief Title:
To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SmokeScreen
Brief Summary:
Purpose This screening protocol is designed to assess PMN neutrophil responsiveness to wood smoke particles WSP and the effect of the GSTM1 null genotype on this response The researches will identify persons responsive and resistant to the inflammatory effect of WSP It is anticipated that the GSTM1 genotype will be a risk factor for increased response to WSP
Detailed Description:
Particulate matter PM is a leading cause of respiratory tract and cardiovascular disease in the United States and world-wide Wood smoke particles WSP derived from wild land and other fires account for a significant fraction of ambient air PM Health effects associated with WSP include acute bronchitis asthma exacerbation pneumonia cough and systemic inflammation While these effects are seen in both healthy and asthmatic individuals many studies indicate that asthmatics have increased susceptibility to the effects of WSP Though WSP-related effects on cardiovascular CV disease are less well documented WSP do contribute to PM levels and PM exposure is linked to CV health effects changes in heart rate variability vascular reactivity and lipid profiles WSP from wild land fires can cause abrupt increases in ambient air PM 25 levels mean levels 250µgm3 peak levels 1000 µgm3 Avoidance of rapidly increasing PM air pollution due to wild land fires is not feasible as many people cannot leave the burn region
This is a screening protocol to ensure that there ultimately will be adequate subjects available for testing gamma tocopherol in an appropriate population It will identify volunteers who have a 10 increase in PMNs following WSP challenge over baseline values SA1 This screening procedure will identify various risk factors that may increase risk of experiencing airway inflammation and related adverse health outcomes following WSP exposure The GSTM1- genotype is a risk factor that has been extensively explored Researchers at the CEMALB have reported that GSTM1- healthy volunteers HVs have increased inflammatory and systemic responses to O3 and various components of PM LPS70 and Diesel exhaust particles Using the 10 increase in PMNs to define PMN responsiveness results showed that GSTM1- volunteers had a 13 fold higher risk of being PMN responders to 006 ppm O3 When examining PMNs as a continuous measure it was observed that GSTM1- volunteers have increased airway PMN response O3 as well as increased airway and systemic PMN response to LPS70
The researchers at the CEMALB have also examined various response features of 27 individuals 13 healthy 4 allergic non asthmatics 10 allergic asthmatics defined as being responsive R n18 or non-responsive NR n9 to O3 based on airway PMN influx PMNs Among the factors explored were inflammatory responses baseline characteristics and gene expression profiles in recovered sputum cells The researchers have also observed that within individuals PMN response to O3 and LPS correlate and anticipate that WSP will induce inflammatory responses via mechanisms similar to those for these pollutants
This is a screening protocol to ensure that there ultimately will be adequate subjects available for testing gamma tocopherol in an appropriate population It will identify volunteers who have a 10 increase in PMNs following WSP challenge over baseline values SA1 This screening procedure will identify various risk factors that may increase risk of experiencing airway inflammation and related adverse health outcomes following WSP exposure The GSTM1- genotype is a risk factor that has been extensively explored Researchers at the CEMALB have reported that GSTM1- healthy volunteers HVs have increased inflammatory and systemic responses to O3 and various components of PM LPS70 and Diesel exhaust particles Using the 10 increase in PMNs to define PMN responsiveness results showed that GSTM1- volunteers had a 13 fold higher risk of being PMN responders to 006 ppm O3 When examining PMNs as a continuous measure it was observed that GSTM1- volunteers have increased airway PMN response O3 as well as increased airway and systemic PMN response to LPS70
The researchers at the CEMALB have also examined various response features of 27 individuals 13 healthy 4 allergic non asthmatics 10 allergic asthmatics defined as being responsive R n18 or non-responsive NR n9 to O3 based on airway PMN influx PMNs Among the factors explored were inflammatory responses baseline characteristics and gene expression profiles in recovered sputum cells The researchers have also observed that within individuals PMN response to O3 and LPS correlate and anticipate that WSP will induce inflammatory responses via mechanisms similar to those for these pollutants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 1R01ES025124-01A1 | NIH | None | httpsreporternihgovquickSearch1R01ES025124-01A1 |