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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Emphysema: Outcomes and Technology Assessment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00675454
• Other study ID #: 565
• Secondary ID: K23HL004236
• Status: Terminated
• Start date: January 2000
• Est. completion date: September 11, 2015

Study information

• Verified date: November 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 802
• Est. completion date: September 11, 2015
• Est. primary completion date: September 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Locations

Country	Name	City	State
United States	Washington University School of Medicine and Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,