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

This study is currently recruiting participants.
Verified February 2017 by Edwin K. Silverman, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608764
First Posted: February 6, 2008
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Edwin K. Silverman, Brigham and Women's Hospital
January 28, 2008
February 6, 2008
February 2, 2017
November 2007
December 2017   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00608764 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Examining the Genetic Factors That May Cause Chronic Obstructive Pulmonary Disease (COPD)
Genetic Epidemiology of Chronic Obstructive Pulmonary Disease
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Genomic DNA, serum, and plasma will be collected and stored.
Non-Probability Sample

Particpants with COPD will include outpatient clinic patients, patients in registries, previous study participants, and COPD Foundation volunteers.

Participants without COPD will include spouses and friends of study participants with COPD and patients at primary care practices.

  • Pulmonary Disease, Chronic Obstructive
  • Emphysema
  • Bronchitis, Chronic
Not Provided
  • NHW COPD Participants
    Non-Hispanic white participants with COPD
  • NHW Control Group
    Non-Hispanic white participants with normal spirometry (do not have COPD)
  • AA COPD Participants
    African-American participants with COPD
  • AA Control Group
    African-American participants with normal spirometry (do not have COPD)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10500
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 80 Years   (Adult, Senior)
Yes
Contact: Edwin K. Silverman, MD, PhD 617-525-0856 ed.silverman@channing.harvard.edu
Contact: James D. Crapo, MD 303-398-1657 CrapoJ@NJHealth.org
United States
 
 
NCT00608764
1428
R01HL089897 ( U.S. NIH Grant/Contract )
R01HL089856 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: COPDGene phenotypic and genotypic data are available through dbGaP.
Edwin K. Silverman, Brigham and Women's Hospital
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: James D. Crapo, MD National Jewish Health
Principal Investigator: Edwin K. Silverman, MD, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
February 2017