Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281216
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2006-01-20
Brief Title:
Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Innate and Adaptive Immunity in COPD Exacerbations Prospective Cohort Study
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 there is a statistical association between the changes from baseline in the levels of two cytokines interleukin IL-17A and IL-6 in the sputum of patients with chronic obstructive pulmonary disease COPD and the severity of acute exacerbations of COPD AE-COPD These sputum cytokine levels are taken as measures of the adaptive immune response IL-17A and the innate immune response IL-6 respectively Sputum will be collected either spontaneously or will be obtained by induction cytokine levels will be measured by ELISA The primary analysis comparisons of sputum cytokine levels between clinical states will be done using random effects modeling
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
A prospective patient cohort will be studied extensively physiologically functionally and immunologically upon enrollment while in the stable state As part of the study participants will be trained in the use of peak flow meters so that they can record daily first morning peak expiratory flow rates PEFR To confirm the range of fluctuations in their basal state participants will be then be followed at three-month intervals for face-to-face interviews and more limited physiological and functional testing described below Participants will also be reminded at each scheduled visit to contact the study coordinator when they feel that an AE-COPD may be present If they do contact the study coordinator they will be evaluated at one of the study sites within 48 hours
A diagnosis of AE-COPD will incorporate a modification of the definition used by the COPD Clinical Research Network CCRN The diagnosis will be made in one of two ways severe AE-COPD will be defined as a change in respiratory symptoms above the participants baseline measurements plus evaluation in the emergency room ER or requiring hospitalization or mild-to-moderate AE-COPD will be defined as a change in respiratory symptoms above the participants baseline measurements and requiring a change in therapy addition of either antibiotics oral steroids or both but without evaluation in the ER or hospitalization In the latter case therapy could be changed either at the advice of the patients own caregivers or a study physician based on clinical judgment or could be self-initiated in the case of participants authorized to do so by their caregiver A concerted effort will be made to capture these milder AE-COPD during both winter and non-winter seasons
Upon enrolling participants the following will be performed review of medical history review of demographic and smoking history physical examination blood and sputum collection six-minute walk test and questionnaires to assess shortness of breath MMRC and University of California San Diego SOBQ sputum production modified Chronic Bronchitis Symptom Questionnaire health status SF-36 and St Georges Respiratory Questionnaire and psychological traits Hospital AnxietyDepression Score Illness Perception Questionnaire Coping Index and an individualized 30-minute clinical interview via telephone
Participants will attend study visits every 3 months to review symptoms During an AE-COPD episode of acute bronchitis sputum and blood will be collected and a five-symptom questionnaire will be filled out
Subjects are reimbursed 25 per scheduled visit and 50 per unscheduled visit at the time of perceived exacerbation to help defray travel expenses
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
A prospective patient cohort will be studied extensively physiologically functionally and immunologically upon enrollment while in the stable state As part of the study participants will be trained in the use of peak flow meters so that they can record daily first morning peak expiratory flow rates PEFR To confirm the range of fluctuations in their basal state participants will be then be followed at three-month intervals for face-to-face interviews and more limited physiological and functional testing described below Participants will also be reminded at each scheduled visit to contact the study coordinator when they feel that an AE-COPD may be present If they do contact the study coordinator they will be evaluated at one of the study sites within 48 hours
A diagnosis of AE-COPD will incorporate a modification of the definition used by the COPD Clinical Research Network CCRN The diagnosis will be made in one of two ways severe AE-COPD will be defined as a change in respiratory symptoms above the participants baseline measurements plus evaluation in the emergency room ER or requiring hospitalization or mild-to-moderate AE-COPD will be defined as a change in respiratory symptoms above the participants baseline measurements and requiring a change in therapy addition of either antibiotics oral steroids or both but without evaluation in the ER or hospitalization In the latter case therapy could be changed either at the advice of the patients own caregivers or a study physician based on clinical judgment or could be self-initiated in the case of participants authorized to do so by their caregiver A concerted effort will be made to capture these milder AE-COPD during both winter and non-winter seasons
Upon enrolling participants the following will be performed review of medical history review of demographic and smoking history physical examination blood and sputum collection six-minute walk test and questionnaires to assess shortness of breath MMRC and University of California San Diego SOBQ sputum production modified Chronic Bronchitis Symptom Questionnaire health status SF-36 and St Georges Respiratory Questionnaire and psychological traits Hospital AnxietyDepression Score Illness Perception Questionnaire Coping Index and an individualized 30-minute clinical interview via telephone
Participants will attend study visits every 3 months to review symptoms During an AE-COPD episode of acute bronchitis sputum and blood will be collected and a five-symptom questionnaire will be filled out
Subjects are reimbursed 25 per scheduled visit and 50 per unscheduled visit at the time of perceived exacerbation to help defray travel expenses
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 |