Examining the Genetic Factors That May Cause Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— COPDGene  

Official title:

Genetic Epidemiology of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00608764
• Other study ID #: 1428
• Secondary ID: U01HL089897U01HL
• Status: Active, not recruiting
• Start date: November 2007
• Est. completion date: December 2027

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is often caused by cigarette smoking. The purpose of this study is to evaluate whether certain genetic factors predispose some smokers to develop COPD more than others.

Description:

COPD is a disease in which the lung airways are damaged and partly obstructed, making it difficult to breathe. Millions of people in the United States have COPD, and it is the third leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Emphysema and long-term bronchitis are the two most common manifestations of the disease. The most common risk factor for developing COPD is cigarette smoking; however, only 15% to 20% of smokers develop COPD in their lifetimes. It is not known why some smokers develop COPD and some do not, but certain genetic factors, combined with exposure to cigarette smoke, may increase the likelihood of developing COPD. This study will analyze DNA from current and former cigarette smokers to identify genetic factors and markers that may indicate a predisposition to developing COPD.

This study will enroll African-American and white cigarette smokers and former cigarette smokers both with and without COPD. Participants will attend one study visit during which they will complete questionnaires about lung symptoms, breathing difficulties, medical and family history, and quality of life. They will also undergo blood collection, a physical exam, lung function testing, and a walking test to measure endurance. Participants will undergo a high resolution computed tomography (CT) chest scan and a medical record review. Study researchers will contact participants up to four times a year for 10 years to collect follow-up medical information. Five-year and ten-year follow-up visits including a similar study protocol as the baseline visit will be performed on all available subjects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10718
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least 10 pack-years of cigarette smoking (although a of nonsmoking controls is also being enrolled)

• Self-designation of non-Hispanic white or African-American

Exclusion Criteria:

• Other lung diseases (except for asthma in participants with COPD)

• Pregnant

• Cancer (other than skin cancer) in the 5 years prior to study entry

• Received antibiotics for a COPD exacerbation in the 1 month prior to study entry

• First- or second-degree relative of a previously enrolled study participant

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Locations

Country	Name	City	State
United States	Ann Arbor VA Medical Center	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	National Jewish Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Houston VA Medical Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	HealthPartners Research Foundation	Minneapolis	Minnesota
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Texas Health Sciences Center at San Antonio	San Antonio	Texas
United States	University of California at San Diego	San Diego	California
United States	Los Angeles Biomedical Research Institute	Torrance	California
United States	Fallon Clinic	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in 1 second (FEV1)		Measured at baseline
Primary	Emphysema, as shown on chest CT scan		Measured at baseline
Primary	Airway wall thickness on chest CT scan		Measured at baseline
Primary	COPD status (COPD participants versus control group participants)		Measured at baseline