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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Brigham and Women's Hospital
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Edwin K. Silverman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00608764
First received: January 28, 2008
Last updated: February 1, 2017
Last verified: February 2017
  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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]

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: December 2017
Estimated Primary Completion Date: December 2017 (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. A five year follow-up visit including a similar study protocol as the baseline visit will be performed on all available subjects.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

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)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608764

Contacts
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

Locations
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
University of California at San Diego Recruiting
San Diego, California, United States, 92103
Contact: Amanda Alvarez    619-471-0818      
Principal Investigator: Joe Ramsdell, MD         
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
Contact: Carmen Lopez-Garcia    310-222-8200      
Principal Investigator: Richard Casaburi, 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: Wayne Hairston    404-755-1361      
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: Leif Skjerli    617-525-2290      
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
Ann Arbor VA Medical Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Lisa McCloskey    734-845-3533      
Principal Investigator: Jeffrey Curtis, MD         
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sara Viland    855-303-5760      
Principal Investigator: Fernando Martinez, MD         
United States, Minnesota
Minneapolis VA Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Doris Stuber    612-467-5203      
Principal Investigator: Dennis Niewoehner, MD         
HealthPartners Research Foundation Recruiting
Minneapolis, Minnesota, United States, 55440
Contact: Natalie Woodruff    952-967-5493      
Principal Investigator: Charlene McEvoy, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Cheryl Stibbe    612-625-1435      
Principal Investigator: Chris Wendt, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Milka Monegro    212-342-4162      
Principal Investigator: R. Graham Barr, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Stephanie Keeting    919-613-6306      
Principal Investigator: Neil MacIntyre, MD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Carla Grabianowski    215-707-2481      
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: Barbara Miller    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: Cali Rose    210-949-3264      
Principal Investigator: Antonio Anzueto, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: James D. Crapo, MD National Jewish Health
Principal Investigator: Edwin K. Silverman, MD, PhD Brigham and Women's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edwin K. Silverman, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00608764     History of Changes
Other Study ID Numbers: 1428  R01HL089897  R01HL089856 
Study First Received: January 28, 2008
Last Updated: February 1, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: COPDGene phenotypic and genotypic data are available through dbGaP.

Keywords provided by Brigham and Women's Hospital:
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Chronic Bronchitis
Genetics
Association Studies
Computed Tomography

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Pulmonary Emphysema
Respiratory Tract Diseases
Disease Attributes
Bronchial Diseases
Emphysema
Bronchitis
Bronchitis, Chronic
Pathologic Processes
Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 24, 2017