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

Emphysema: Outcomes and Technology Assessment

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive; Emphysema

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 Type: Observational
• Enrollment (Actual): 802

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine and Barnes-Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Roger D. Yusen, MD, MPH, Washington University School of Medicine, St. Louis

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): September 11, 2015
• Study Completion (Actual): September 11, 2015

Study Registration Dates

• First Submitted: May 7, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 9, 2008

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; COPD; Lung Transplant; Lung Volume Reduction Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 565; K23HL004236 (U.S. NIH Grant/Contract)