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Evaluating the Effects of Surgical and Non-Surgical Treatment Options in People With Emphysema
This study is enrolling participants by invitation only.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00675454
  Purpose

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
Pulmonary Disease, Chronic Obstructive
Emphysema

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Emphysema Lung Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Emphysema: Outcomes and Technology Assessment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 300
Study Start Date: January 2000
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with moderate to severe emphysema who are undergoing pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation.

Criteria

Inclusion Criteria:

  • Diagnosed with emphysema
  • Referred for pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation

Exclusion Criteria:

  • Non-obstructive lung disease
  • Chronic obstructive pulmonary disease (COPD) that is not predominantly due to emphysema
  • Inability to read English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675454

Locations
United States, Missouri
Washington University School of Medicine and Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Investigators
Principal Investigator: Roger D. Yusen, MD, MPH Washington University School of Medicine, St. Louis
  More Information

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

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
COPD
Lung Volume Reduction Surgery
Lung Transplant
Quality of Life

Study placed in the following topic categories:
Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Quality of Life
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009