Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005549
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2000-05-25
Brief Title:
Isocyanate Antigens and T Cells That Cause Asthma
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
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:
To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated airway inflammation
Detailed Description:
BACKGROUND
Isocyanates are a group of highly reactive widely used low-molecular weight chemicals and are the most commonly reported cause of occupation asthma in developed countries Yet the mechanisms by which isocyanates cause asthma are not well defined
DESIGN NARRATIVE
The study investigates isocyanate antigen-driven T-cell responses in vitro- following in vivo exposure using patient samples acquired through collaboration with ongoing field epidemiological and clinical studies The study compares isocyanate antigen-reactive T-cells from primary exposure sites skinlung with those from blood to evaluate potential routes of sensitization and identify diagnostic indicators of isocyanate sensitivitysusceptibility Specifically the study generates and characterizes hexamethylene diisocyanate HDI antigens including isocyanate metabolites and isocyanate conjugated t normal human and foreign proteins evaluates the T-cell antigenicity of the HDI antigens based on blood and lung lymphocyte proliferation cytokine production and phenotype in order to identify the molecular form of HDI that initiates airway cytokine production in asthma patients establishes T-cell lines from the skin lung and peripheral blood of HDI asthma patients and characterizes the phenotype antigen specificity cytokine production and TCR expression of isocyanate responsive T-cells in these different compartments compares isocyanate responsive of T-cells found in the skin lung and blood and correlates with clinical sensitivity to determine characteristics associated with exposure and sensitization leading to clinical asthma
The study was renewed in FY 2002 to extend follow-up and analysis through March 2007
Isocyanates are a group of highly reactive widely used low-molecular weight chemicals and are the most commonly reported cause of occupation asthma in developed countries Yet the mechanisms by which isocyanates cause asthma are not well defined
DESIGN NARRATIVE
The study investigates isocyanate antigen-driven T-cell responses in vitro- following in vivo exposure using patient samples acquired through collaboration with ongoing field epidemiological and clinical studies The study compares isocyanate antigen-reactive T-cells from primary exposure sites skinlung with those from blood to evaluate potential routes of sensitization and identify diagnostic indicators of isocyanate sensitivitysusceptibility Specifically the study generates and characterizes hexamethylene diisocyanate HDI antigens including isocyanate metabolites and isocyanate conjugated t normal human and foreign proteins evaluates the T-cell antigenicity of the HDI antigens based on blood and lung lymphocyte proliferation cytokine production and phenotype in order to identify the molecular form of HDI that initiates airway cytokine production in asthma patients establishes T-cell lines from the skin lung and peripheral blood of HDI asthma patients and characterizes the phenotype antigen specificity cytokine production and TCR expression of isocyanate responsive T-cells in these different compartments compares isocyanate responsive of T-cells found in the skin lung and blood and correlates with clinical sensitivity to determine characteristics associated with exposure and sensitization leading to clinical asthma
The study was renewed in FY 2002 to extend follow-up and analysis through March 2007
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062622 | NIH | None | httpsreporternihgovquickSearchR01HL062622 |