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Clinical Trials/NCT00608764
NCT00608764
Active, not recruiting
Not Applicable

Genetic Epidemiology of Chronic Obstructive Pulmonary Disease (COPDGene)

Brigham and Women's Hospital20 sites in 1 country10,718 target enrollmentNovember 1, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Brigham and Women's Hospital
Enrollment
10718
Locations
20
Primary Endpoint
Airway wall thickness on chest CT scan
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief 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.

Detailed 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 15 years to collect follow-up medical information. Five-year, ten-year, and fifteen-year follow-up visits including a similar study protocol as the baseline visit will be performed on all available subjects.

Registry
clinicaltrials.gov
Start Date
November 1, 2007
End Date
August 1, 2028
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Edwin K. Silverman

Professor of Medicine

Brigham and Women's Hospital

Eligibility Criteria

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)
  • 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

Outcomes

Primary Outcomes

Airway wall thickness on chest CT scan

Time Frame: Measured at baseline

COPD status (COPD participants versus control group participants)

Time Frame: Measured at baseline

Forced expiratory volume in 1 second (FEV1)

Time Frame: Measured at baseline

Emphysema, as shown on chest CT scan

Time Frame: Measured at baseline

Study Sites (20)

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