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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00608764 |
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: | Cohort, Cross-Sectional |
| Official Title: | Genetic Epidemiology of Chronic Obstructive Pulmonary Disease |
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
|
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AA Control Group
African-American participants with normal spirometry (do not have COPD)
|
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 fourth 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 with COPD will undergo a high resolution computed tomography (CT) chest scan and a medical record review. Study researchers will contact participants twice 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:
Exclusion Criteria:
Contacts and Locations| Contact: Edwin K. Silverman, MD, PhD | 617-525-0856 | ed.silverman@channing.harvard.edu |
| Contact: James D. Crapo, MD | 303-398-1720 | crapoj@njc.org |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35249 | |
| Contact: Don Davis 205-996-6601 | |
| Principal Investigator: Mark Dransfield, MD | |
| United States, California | |
| Los Angeles Biomedical Research Institute | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Carmen Lopez-Garcia 310-222-8200 | |
| Principal Investigator: Richard Casaburi, MD | |
| University of California at San Diego | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Cathy Calvillo 619-471-0818 | |
| Principal Investigator: Joe Ramsdell, MD | |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Christina Schnell 303-398-1772 | |
| Principal Investigator: Russell Bowler, MD | |
| United States, Georgia | |
| Morehouse School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30310 | |
| Contact: Jolita Wainwright 404-752-1877 | |
| Contact: Iva Katon-Benitez 404-616-1415 | |
| Principal Investigator: Marilyn Foreman, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Kim Sprenger 319-353-8862 | |
| Principal Investigator: Geoffrey McLennan, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Teresa Concordia 410-550-2449 | |
| Principal Investigator: Robert Wise, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Grace Brown 617-732-6272 | |
| Principal Investigator: Dawn DeMeo, MD | |
| Principal Investigator: Craig Hersh, MD | |
| Fallon Clinic | Recruiting |
| Worcester, Massachusetts, United States, 01608 | |
| Contact: Diane Kirk 508-368-3929 | |
| Principal Investigator: Richard Rosiello, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Candace Flaherty 734-647-6399 | |
| Principal Investigator: Fernando Martinez, MD | |
| Ann Arbor VA Medical Center | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48105 | |
| Contact: Lisa McCloskey 734-845-3533 | |
| Principal Investigator: Jeffrey Curtis, MD | |
| United States, Minnesota | |
| HealthPartners Research Foundation | Recruiting |
| Minneapolis, Minnesota, United States, 55440 | |
| Contact: Natalie Woodruff 952-967-5493 | |
| Principal Investigator: Charlene McEvoy, MD | |
| University of Minnesota | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Cheryl Stibbe 612-625-1435 | |
| Principal Investigator: Chris Wendt, MD | |
| Minneapolis VA Medical Center | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Doris Stuber 612-467-5203 | |
| Principal Investigator: Dennis Niewoehner, MD | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Adina Lemeshow 212-305-9821 | |
| Principal Investigator: R. Graham Barr, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Kim Hamilton 919-684-9428 | |
| Contact: Stephanie Keeting 919-613-6306 | |
| Principal Investigator: Neil MacIntyre, MD | |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Gretel Ortiz 215-707-9844 | |
| Principal Investigator: Gerard Criner, MD | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Patty Tomko 412-623-5909 | |
| Principal Investigator: Frank Sciurba, MD | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Mustafa Atik 713-798-2683 | |
| Principal Investigator: Nicola Hanania, MD | |
| Houston VA Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Dorothy Williams 713-794-7668 | |
| Principal Investigator: Amir Sharafkhaneh, MD | |
| University of Texas Health Sciences Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Nita Zaragoza 210-949-3264 | |
| Principal Investigator: Antonio Anzueto, MD | |
| Principal Investigator: | James D. Crapo, MD | National Jewish Health |
| Principal Investigator: | Edwin K. Silverman, MD, PhD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Brigham and Women's Hospital ( Edwin K. Silverman, MD, PhD ) |
| Study ID Numbers: | 1428, 1 R01 HL089856, 1 R01 HL089897 |
| Study First Received: | January 28, 2008 |
| Last Updated: | January 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00608764 |
| Health Authority: | United States: Federal Government |
|
Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic Bronchitis |
Genetics Association Studies Computed Tomography |
|
Pulmonary Emphysema Emphysema Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Chronic Disease Bronchitis Pulmonary Disease, Chronic Obstructive |
|
Disease Attributes Pathologic Processes Bronchial Diseases |
