Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2021-09-08
2026-04-30
Brief Summary
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The study has three main goals:
* To use CT scan imaging to identify which smokers will develop COPD.
* To identify biomarkers predictive of smokers that will develop COPD.
* To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD.
Procedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Controls
Participants with no smoking history (\< 100 cigarettes in lifetime); pre-bronchodilator FEV1/FVC ≥ 0.70; pre-bronchodilator FEV1 ≥ 80% predicted; and pre-bronchodilator FVC ≥ 80% predicted.
No interventions assigned to this group
Gold 0
Participants graded as GOLD 0 by the GOLD grading system: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 ≥ 80% predicted.
GOLD stands for the Global initiative for Chronic Obstructive Lung Disease.
No interventions assigned to this group
Preserved Ratio Impaired Spirometry (PRISm)
Participants with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 \< 80% predicted.
No interventions assigned to this group
GOLD 1 - 2
Participants graded as GOLD 0 by the GOLD grading system: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 ≥ 50% predicted.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Approximately one-third of the 960 will be GOLD 0 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \> 0.70 and FEV1 \> 80% predicted.
* Approximately one-third of the 960 will be Preserved Ratio Impaired Spirometry (PRISm) participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \> 0.70 and FEV1 \< 80% predicted.
* Approximately one-third of the 960 will be GOLD 1-2 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 \> 50% predicted.
Exclusion Criteria
* Current (i.e., at the time of the visit) Global Initiative for Asthma (GINA) Step 4 or higher therapy (medium dose inhaled corticosteroids (ICS)/long-acting beta agonist (LABA) or high dose ICS or add-on long-acting muscarinic agonist (LAMA); Medium dose \> 250 fluticasone propionate, = 100 fluticasone furoate, \> 200 beclomethasone, \> 400 budesonide, \> 220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS; or
* Three or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months; or
* One asthma hospitalization in the past 12 months.
* Concurrent participation in a therapeutic trial where treatment is blinded.
* Active pregnancy at the time of the baseline visit or planning to become pregnant during the course of the study. This special population is being excluded to minimize potential for fetal radiation exposure.
* Cognitive dysfunction that prevents the participant from completing study procedures.
* BMI \> 35.0 kg/m\^2 at baseline, due to the effects of body weight on CT scan imaging quality.
* The presence of a respiratory condition other than COPD (including chronic bronchitis and emphysema) or asthma, such as interstitial lung disease or pulmonary fibrosis, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g., dyspnea or decreased exercise tolerance).
* Any illness expected to cause mortality in the next three years.
* Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.
* History of thoracic radiation or thoracic surgery with resection of lung tissue.
* Known HIV/AIDS infection.
* Current illicit substance abuse, excluding marijuana.
* History of or current use of IV Ritalin.
* History of or current use of heroin.
* History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever.
30 Years
55 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of North Carolina, Chapel Hill
OTHER
Columbia University
OTHER
Johns Hopkins University
OTHER
National Jewish Health
OTHER
University of Alabama at Birmingham
OTHER
University of California, Los Angeles
OTHER
University of Illinois at Chicago
OTHER
University of Iowa
OTHER
University of Michigan
OTHER
University of Utah
OTHER
Wake Forest University Health Sciences
OTHER
Temple University
OTHER
University of California, San Francisco
OTHER
COPD Foundation
OTHER
Weill Medical College of Cornell University
OTHER
Mayo Clinic
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Fernando J Martinez
Professor
Principal Investigators
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Fernando J Martinez, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
MeiLan K Han, MD,MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Jeffrey L Curtis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
University of Illinois Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Wake Forest
Winston-Salem, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Victor Ortega, MD, PhD
Role: primary
Igor Barjaktarevic, MD, PhD
Role: primary
Claudia Onofrei, MD
Role: primary
Jerry Krishnan, MD, PhD
Role: primary
Alejandro Comellas, MD
Role: primary
Nadia Hansel, MD, MPH
Role: primary
R. Graham Barr, MD, PhD
Role: primary
Jessica Bon, MD
Role: primary
Nathaniel Marchetti, DO
Role: primary
Robert Paine, MD
Role: primary
Other Identifiers
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STUDY00002081
Identifier Type: -
Identifier Source: org_study_id
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