Comparison of Alveolar Macrophages in Healthy Individuals Versus Individuals With COPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00281203|
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : July 16, 2013
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive||Procedure: blood drawing Procedure: fiberoptic bronchoscopy|
COPD is one of the most pressing healthcare problems facing our nation. Acute exacerbations of COPD (AE-COPD) are 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.
Bronchoscopies will be performed on healthy volunteers. Subjects are reimbursed $30 for the initial visit and $150 at completion of the bronchoscopy to help defray travel expenses and for the time spent participating as a volunteer.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Innate and Adaptive Immunity in COPD Exacerbations: Bronchoscopies on Healthy Volunteers|
|Study Start Date :||September 2005|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
Must be free of serious diseases that might make it dangerous to undergo bronchoscopy.
Procedure: blood drawing
blood will be drawn on the entry visit and will starting the intravenous (IV) line on the day of bronchoscopyProcedure: fiberoptic bronchoscopy
A flexible instrument will be passed through the mouth and into the lungs. Portions of the lungs will be washed, by injecting and immediately suctioning out a small amount of fluid. The entire return will be used for research purposes, and no results will be reported to the participant. Bronchoscopy is performed once.
- alveolar macrophage functions in vitro [ Time Frame: day of bronchoscopy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281203
|United States, Michigan|
|University of Michigan at Ann Arbor|
|Ann Arbor, Michigan, United States, 48105|
|Study Chair:||Jeffrey L. Curtis||University of Michigan at Ann Arbor|