Evaluating the Effects of Surgical and Non-Surgical Treatment Options in People With Emphysema

Sponsor
Washington University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT00675454
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
802
1
188.3
4.3

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    802 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Emphysema: Outcomes and Technology Assessment
    Study Start Date :
    Jan 1, 2000
    Actual Primary Completion Date :
    Sep 11, 2015
    Actual Study Completion Date :
    Sep 11, 2015

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      35 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Washington University School of Medicine and Barnes-Jewish Hospital Saint Louis Missouri United States 63110

      Sponsors and Collaborators

      • Washington University School of Medicine
      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      • Principal Investigator: Roger D. Yusen, MD, MPH, Washington University School of Medicine, St. Louis

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Washington University School of Medicine
      ClinicalTrials.gov Identifier:
      NCT00675454
      Other Study ID Numbers:
      • 565
      • K23HL004236
      First Posted:
      May 9, 2008
      Last Update Posted:
      Dec 2, 2021
      Last Verified:
      Nov 1, 2021
      Keywords provided by Washington University School of Medicine
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Dec 2, 2021