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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00756522 |
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD have difficulty breathing because of lung damage. However, for many people with COPD, while some areas of the lungs are damaged, other nearby areas are not. This study will examine lung tissue from people with and without COPD who are undergoing lung transplantation to investigate how and why certain areas of the lungs are damaged in some people but not others.
Condition |
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Pulmonary Disease, Chronic Obstructive |
Study Type: | Observational |
Study Design: | Cross-Sectional |
Official Title: | Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms for COPD. Detection: Lung Imaging and Profiling (Project 1) |
Plasma, serum, isolated RNA and DNA, and lung tissue
Estimated Enrollment: | 48 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants in this study will be adults with a clinically established need for lung transplantation and who are listed at Barnes-Jewish Hospital for lung transplantation because of COPD.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for 3-Helium MRI Procedure:
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 |
Responsible Party: | Pulmonary and Critical Care Medicine, Washington University School of Medicine ( Richard Pierce, PhD ) |
Study ID Numbers: | 575, P50 HL084922-01 |
Study First Received: | September 19, 2008 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00756522 History of Changes |
Health Authority: | United States: Food and Drug Administration |
COPD |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Chronic Disease Pulmonary Disease, Chronic Obstructive |
Disease Attributes Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Chronic Disease Pulmonary Disease, Chronic Obstructive |