Examining the Genetic Factors That May Cause Chronic Obstructive Pulmonary Disease (COPD) (COPDGene)
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Pulmonary Disease, Chronic Obstructive Emphysema Bronchitis, Chronic |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Genetic Epidemiology of Chronic Obstructive Pulmonary Disease |
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
- Emphysema, as shown on chest CT scan [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
- Airway wall thickness on chest CT scan [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
- COPD status (COPD participants versus control group participants) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Genomic DNA, serum, and plasma will be collected and stored.
| Estimated Enrollment: | 10500 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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)
|
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 5 years to collect follow-up medical information.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| University of California at San Diego | |
| San Diego, California, United States, 92103 | |
| Los Angeles Biomedical Research Institute | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Georgia | |
| Morehouse School of Medicine | |
| Atlanta, Georgia, United States, 30310 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Fallon Clinic | |
| Worcester, Massachusetts, United States, 01608 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Ann Arbor VA Medical Center | |
| Ann Arbor, Michigan, United States, 48105 | |
| United States, Minnesota | |
| HealthPartners Research Foundation | |
| Minneapolis, Minnesota, United States, 55440 | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Minneapolis VA Medical Center | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Houston VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Sciences Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | James D. Crapo, MD | National Jewish Health |
| Principal Investigator: | Edwin K. Silverman, MD, PhD | Brigham and Women's Hospital |
More Information
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edwin K. Silverman, MD, PhD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00608764 History of Changes |
| Other Study ID Numbers: | 1428, 1 U01 HL089856, 1 U01 HL089897 |
| Study First Received: | January 28, 2008 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic Bronchitis |
Genetics Association Studies Computed Tomography |
Additional relevant MeSH terms:
|
Bronchitis Bronchitis, Chronic Chronic Disease Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders |
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013