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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: | NCT00740337 |
Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the United States. There is no cure and the disease gets worse over time. Although it usually occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and without COPD to determine why some COPD symptoms occur in some people and not others.
Condition |
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Pulmonary Disease, Chronic Obstructive |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4) |
Plasma, serum, isolated RNA and DNA, lung tissue
Estimated Enrollment: | 80 |
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) |
Groups/Cohorts |
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COPD
Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).
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Control
Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.
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COPD is a chronic lung disease in which the lungs' airways and balloon-like air sacs, called alveoli, are damaged, lose their shape, and become floppy. As a result, they cannot fully inflate to allow the maximum amount of air through. COPD is usually the result of many years of cigarette smoking. Breathing in other kinds of lung irritants, such as pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD. Some people with COPD have an excess of mucus in their lungs, possibly caused by an overactive immune response, which can lead to coughing and shortness of breath. Although cigarette smoking seems to make this symptom worse, researchers are not sure why it occurs in some people and not others. This study will examine and compare blood and lung tissue samples from smokers and nonsmokers with and without COPD to determine what physiological differences, environmental factors, genes, and biomarkers contribute to the development of and symptoms associated with COPD.
Before their scheduled lung resection surgery, participants in this study will attend one study visit. It will last approximately 1 to 2 hours and will consist of answering questions about medical history, filling out health questionnaires, and providing a blood sample. After the surgery, study researchers will take the lung tissue that was removed and examine it in a laboratory. Participants will be contacted by study staff if, when examining the lung tissue, researchers discover that a participant has a medical disorder that current treatment can stop or improve. Also, participants will be contacted 5 years after study entry to answer brief questions about their health.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People in this study will be invited to participate if they plan to undergo lung resection surgery at BJH.
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Michael J. Holtzman, MD | Pulmonary and Critical Care, Washington University School of Medicine |
Responsible Party: | Pulmonary and Critical Care, Washington University in St. Louis ( Michael J. Holtzman, MD, Professor of Medicine ) |
Study ID Numbers: | 582, P50 HL084922-01 |
Study First Received: | August 20, 2008 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00740337 |
Health Authority: | United States: Federal Government |
Chronic Obstructive Pulmonary Disease COPD Emphysema |
Natural Killer T-cell Interleukin-13 Innate Immune Signaling |
Pulmonary Emphysema Emphysema Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Chronic Disease Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes |