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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: | NCT00675454 |
Emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to breathing difficulties. Treatment options for people with emphysema include pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation. This study will observe people with emphysema to assess the effect of these treatment therapies on their quality of life and long-term health.
Condition |
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Pulmonary Disease, Chronic Obstructive Emphysema |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Emphysema: Outcomes and Technology Assessment |
Estimated Enrollment: | 300 |
Study Start Date: | January 2000 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Emphysema is a progressive lung disease that results in shortness of breath and a reduced capacity for physical activity. It is caused by inflammation within the small air sacs and small airways of the lungs, which can lead to the destruction of the air sac walls and eventually to airway collapse. Treatment options for emphysema include both non-surgical and surgical interventions. Pulmonary rehabilitation, a non-surgical treatment, includes a combination of education, exercise training, nutrition advice, and smoking cessation programs. The goal of pulmonary rehabilitation is to increase exercise tolerance and reduce breathing difficulties. Two surgical treatment options include lung volume reduction surgery, in which small amounts of damaged lung tissue are removed, and lung transplantation, in which a person's damaged lung is replaced with a healthy lung from a donor. While these surgical options may offer potential improvements in quality of life, they also impose substantial risks, including infections, pneumonia, or even death. In this study, researchers will follow participants over a long period of time to assess the effects of pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation on health outcomes and quality of life.
This study will enroll people with moderate to severe emphysema who have undergone pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation. Participants will attend annual study visits and will complete computerized interviews and health-related questionnaires that will assess quality of life factors. Study researchers will also review participants' medical records to collect information on lung function and blood test results.
Ages Eligible for Study: | 35 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants with moderate to severe emphysema who are undergoing pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation.
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine and Barnes-Jewish Hospital | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Roger D. Yusen, MD, MPH | Washington University School of Medicine, St. Louis |
Responsible Party: | Washington University School of Medicine, St. Louis ( Roger D. Yusen, MD, MPH ) |
Study ID Numbers: | 565, K23 HL004236 |
Study First Received: | May 7, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00675454 |
Health Authority: | United States: Federal Government |
COPD Lung Volume Reduction Surgery Lung Transplant Quality of Life |
Pulmonary Emphysema Emphysema Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Quality of Life Chronic Disease Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes |