Analyzing Lung Tissue in People With and Without Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
|ClinicalTrials.gov Identifier: NCT00756522|
Recruitment Status : Unknown
Verified September 2012 by Washington University School of Medicine.
Recruitment status was: Enrolling by invitation
First Posted : September 22, 2008
Last Update Posted : September 17, 2012
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Other: There is no intervention. Study is observational.|
COPD is a common lung disease and is the fourth most common cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath,and wheezing. There is no cure for COPD, and the disease worsens over time. Treatment can include stopping smoking, taking medications, receiving supplemental oxygen, and in severe cases, undergoing lung transplantation. COPD is usually the result of many years of cigarette smoking, but it remains unknown exactly how cigarette smoking causes this disease.
One reason that people with COPD experience shortness of breath and cough is because the lung airways are partly damaged and obstructed. In healthy people, oxygen is breathed in and then passes easily into the bloodstream through bunches of small air sacs that fill the lungs. In people with COPD, these air sacs are damaged, making it difficult for oxygen to pass into the bloodstream. However, even in people with severe COPD, the air sacs in some areas of the lungs continue to work, even though neighboring air sacs are damaged. It is possible that an overactive immune response may cause the air sac damage and that some people with COPD are more prone than others to such immune system abnormalities. By examining the differences in lung tissue in people with and without COPD who are undergoing a lung transplant, this study will investigate why some people's immune systems cause lung damage and others do not and how and why some air sacs are damaged while other nearby air sacs are not. Study researchers will also examine whether genetic factors play a role in the development and severity of COPD.
This study will enroll people with COPD who are undergoing lung transplantation. Before the lung transplantation surgery, participants will attend one study visit, which will include a medical history review, height and weight measurements, and a blood collection. A portion of blood will be stored for future genetic research. Participants will also complete questionnaires to collect information on activities, health, and quality of life. Some participants will undergo a 3-Helium magnetic resonance imaging (MRI) procedure, which is an imaging technique that allows doctors to see the air spaces inside of the lungs. After the lung transplantation surgery, study researchers will collect lung tissue from surgery. Study researchers will contact participants at the end of the study to collect follow-up medical information.
|Study Type :||Observational|
|Actual Enrollment :||63 participants|
|Official Title:||Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms for COPD. Detection: Lung Imaging and Profiling (Project 1)|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
Other: There is no intervention. Study is observational.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756522
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Richard Pierce, PhD||Washington University School of Medicine, Pulmonary and Critical Care Division|
|Study Chair:||Michael Holtzman, MD||Washington University School of Medicine, Pulmonary and Critical Care Division|