This trial is active, not recruiting.

Conditions pulmonary disease, chronic obstructive, emphysema, bronchitis, chronic
Sponsor Brigham and Women's Hospital
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date November 2007
End date November 2017
Trial size 10500 participants
Trial identifier NCT00608764, 1428, R01HL089856, R01HL089897


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Non-Hispanic white participants with COPD
Non-Hispanic white participants with normal spirometry (do not have COPD)
African-American participants with COPD
African-American participants with normal spirometry (do not have COPD)

Primary Outcomes

Forced expiratory volume in 1 second (FEV1)
time frame: Measured at baseline
Emphysema, as shown on chest CT scan
time frame: Measured at baseline
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

Eligibility Criteria

Male or female participants from 45 years up to 80 years old.

Inclusion Criteria: - At least 10 pack-years of cigarette smoking - Spirometry that meets one of four Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages or normal (FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] greater than 0.7) - 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

Additional Information

Official title Genetic Epidemiology of Chronic Obstructive Pulmonary Disease
Principal investigator James D. Crapo, MD
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 5 years to collect follow-up medical information. A five year follow-up visit including a similar study protocol as the baseline visit will be performed on all available subjects.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.