Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281229
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2006-01-20
Brief Title:
T Lymphocyte Cells in Individuals Experiencing an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Innate and Adaptive Immunity in COPD Exacerbations Surgical Volunteers
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The purpose of this study is to determine whether the lungs of individuals with chronic obstructive pulmonary disease COPD contain resident memory T lymphocytes that can produce a combination of cytokines that induce the symptoms of an acute exacerbation of COPD AE-COPD Specifically the study will determine cell-surface receptors of lung T cells in comparison with blood T cells from the same subject and will examine anti-CD3-activated blood or lung T cells for interleukin IL-6 and interferon-gamma production in response to IL-18 and for IL-17A production in response to recombinant IL-23
Detailed Description:
BACKGROUND
COPD is one of the most pressing healthcare problems facing our nation AE-COPD is responsible for the bulk of healthcare costs and much of the morbidity and decline in health status among individuals with this common disease The lack of accepted animal models of AE-COPD necessitates novel approaches using human samples Advances in the understanding of the pathogenesis have been slowed in part due to controversy as to how exacerbations should be defined The prevailing paradigm has defined AE-COPD as event-based Such definitions clearly identify groups of patients with accelerated loss of pulmonary function and increased mortality However limited data show that symptom-based definitions of AE-COPD also capture episodes inducing significant morbidity and functional decline and hence of concern to patients Fundamental mechanisms are lacking to explain AE-COPD defined by either means
Controversy also surrounds triggers of AE-COPD Bacteria and viruses are involved in some episodes but the relative importance of each is intertwined with disputes over the definition of AE-COPD Progress at linking specific pathogens to molecular pathogenesis has been slow both due to their diversity and to the high rates of bacterial colonization of patients with COPD even in the stable state Moreover in many AE-COPD cases no pathogen can be identified Without negating the value of analyzing infections with specific species of pathogens it appears that progress in molecular pathogenesis could be accelerated by focusing on unifying features of the pulmonary immune response during AE-COPD
DESIGN NARRATIVE
The research protocol involves isolating lung lymphocytes from surgical specimens of patients already undergoing clinically indicated lung resections Surgical lung resections may be performed either by open thoracotomy or by video-assisted thoracoscopic surgery VATS and could include pneumonectomies lobectomies or wedge-excisions as dictated by clinical care of the patient This protocol will exclusively use tissue that is of excess after a clinical diagnosis is established The setting is the operating rooms at the Ann Arbor VA Hospital or the University of Michigan Hospital System Subjects will be recruited from the outpatient clinics but will be inpatients at the time of surgery
Subjects will not undergo any additional procedures beyond routine clinical care as a result of participating in this protocol However it is anticipated that the study will have access to the medical record to extract results of demographic data including occupational exposures and smoking history pulmonary function testing and results of imaging and other staging studies
COPD is one of the most pressing healthcare problems facing our nation AE-COPD is responsible for the bulk of healthcare costs and much of the morbidity and decline in health status among individuals with this common disease The lack of accepted animal models of AE-COPD necessitates novel approaches using human samples Advances in the understanding of the pathogenesis have been slowed in part due to controversy as to how exacerbations should be defined The prevailing paradigm has defined AE-COPD as event-based Such definitions clearly identify groups of patients with accelerated loss of pulmonary function and increased mortality However limited data show that symptom-based definitions of AE-COPD also capture episodes inducing significant morbidity and functional decline and hence of concern to patients Fundamental mechanisms are lacking to explain AE-COPD defined by either means
Controversy also surrounds triggers of AE-COPD Bacteria and viruses are involved in some episodes but the relative importance of each is intertwined with disputes over the definition of AE-COPD Progress at linking specific pathogens to molecular pathogenesis has been slow both due to their diversity and to the high rates of bacterial colonization of patients with COPD even in the stable state Moreover in many AE-COPD cases no pathogen can be identified Without negating the value of analyzing infections with specific species of pathogens it appears that progress in molecular pathogenesis could be accelerated by focusing on unifying features of the pulmonary immune response during AE-COPD
DESIGN NARRATIVE
The research protocol involves isolating lung lymphocytes from surgical specimens of patients already undergoing clinically indicated lung resections Surgical lung resections may be performed either by open thoracotomy or by video-assisted thoracoscopic surgery VATS and could include pneumonectomies lobectomies or wedge-excisions as dictated by clinical care of the patient This protocol will exclusively use tissue that is of excess after a clinical diagnosis is established The setting is the operating rooms at the Ann Arbor VA Hospital or the University of Michigan Hospital System Subjects will be recruited from the outpatient clinics but will be inpatients at the time of surgery
Subjects will not undergo any additional procedures beyond routine clinical care as a result of participating in this protocol However it is anticipated that the study will have access to the medical record to extract results of demographic data including occupational exposures and smoking history pulmonary function testing and results of imaging and other staging studies
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 |
|---|---|---|---|
| R01HL082480 | NIH | None | httpsreporternihgovquickSearchR01HL082480 |