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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edwin K. Silverman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00608764
First received: January 28, 2008
Last updated: July 22, 2013
Last verified: July 2013
  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 ] [ 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 2017
Estimated Primary Completion Date: November 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
Genders Eligible for Study:   Both
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
  • 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
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

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
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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 Brigham and Women's Hospital

Additional 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, 1 U01 HL089856, 1 U01 HL089897
Study First Received: January 28, 2008
Last Updated: July 22, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 19, 2014