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SPIROMICS Study of Early COPD Progression (SOURCE) (SOURCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05033990
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : April 28, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Columbia University
Johns Hopkins University
National Jewish Health
University of Alabama at Birmingham
University of California, Los Angeles
University of Illinois at Chicago
University of Iowa
University of Michigan
University of Utah
Wake Forest University Health Sciences
Temple University
University of California, San Francisco
COPD Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

This is an observational study of 600 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals.

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.


Condition or disease
COPD, Early-Onset

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SPIROMICS Study of Early COPD Progression (SOURCE)
Actual Study Start Date : September 8, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : April 2025

Group/Cohort
Healthy Controls
Participants with no smoking history (< 100 cigarettes in lifetime); post-bronchodilator FEV1/FVC > 0.70; post-bronchodilator FEV1 > 80% predicted; and post-bronchodilator FVC > 80% predicted.
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.

Preserved Ratio Impaired Spirometry (PRISm)
Participants with with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC > 0.70 and FEV1 < 80% predicted.
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 50-80% predicted.



Primary Outcome Measures :
  1. PRM fSAD [ Time Frame: Year 2-5 ]
    Parametric Response Mapping captures the change in lung density between matched inspiratory and expiratory images thereby enabling the distinction between normal lung parenchyma (PRMNORM), emphysema (PRMEMPH), and non-emphysematous air trapping referred to as functional small airway disease (PRMfSAD).


Biospecimen Retention:   Samples With DNA
Plasma, serum, RNA, DNA, exhaled breath condensate, nasal swab, sputum, urine, and stool samples will be collected.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
12 clinical centers across the US will enroll a total of 600 participants, 30-55 years old, both sexes, all races, and all ethnicities. The participants will include never-smokers (n=20) and GOLD stage 0-2 participants (n=580).
Criteria

Inclusion Criteria:

  • 20 of the 600 will be healthy controls: ages 30-55 years; with no smoking history (< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 0.70; pre-bronchodilator FEV1 ≥ 80% predicted; pre-bronchodilator FVC ≥ 80% predicted; and willingness to also participate in the bronchoscopy sub-study.
  • Approximately one-third of the 580 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. This early COPD group has been chosen because it is not currently well-represented in COPDGene and SPIROMICS cohorts.
  • Approximately one-third of the 580 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. This early COPD group was enrolled in small numbers in the COPDGene study, but was excluded from SPIROMICS.
  • Approximately one-third of the 580 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. This early COPD group has been chosen because it is also not currently well-represented in the first funded phase of the COPDGene and SPIROMICS cohorts.

Exclusion Criteria:

  • Severe asthma, which is defined as any of the following:

    • 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 or asthma, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033990


Contacts
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Contact: Lori A Bateman, MS 9199623266 lbateman@email.unc.edu
Contact: David Couper, PhD 9199623229 david_couper@unc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Mark Dransfield, MD       mdransfield@uabmc.edu   
Contact: Sonya Hardy    (205) 966-6601    sonyahardy@uabmc.edu   
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Igor Barjaktarevic, MD, PhD         
Contact: Roslynn Marzan-McGill, CPT, CCRP    (310) 825-2616    rmcgill@mednet.ucla.edu   
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Prescott G. Woodruff, MD, MPH    415-479-3370    prescott.woodruff@ucsf.edu   
Contact: Jennipher Jose       Jennipher.Jose@ucsf.edu   
United States, Colorado
National Jewish Health Not yet recruiting
Denver, Colorado, United States, 80206
Contact: Russell Bowler, MD, PhD         
Contact: Alex Johnson, MSW    (303) 398-1943    jonesa@njhealth.org   
United States, Illinois
University of Illinois Chicago Not yet recruiting
Chicago, Illinois, United States, 60608
Contact: Jerry Krishnan, MD, PhD         
Contact: Julie Delisa    (855) 494-3393    breathe@uic.edu   
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Alejandro Comellas, MD         
Contact: Mike Wurth    (319) 356-1785    mike-wurth@uiowa.edu   
United States, Maryland
Johns Hopkins Bayview Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Nadia Hansel, MD, MPH         
Contact: Cheryl Clare    (410) 550-2864    Cdaniel9@jhu.edu   
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48130
Contact: Meilan Han, MD, MPH       mrking@med.umich.edu   
Contact: Crystal Cutlip    (734) 647-6399    ccutlip@med.umich.edu   
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: R. Graham Barr, MD, PhD         
Contact: Michael Sheffey    (347) 835- 8180    ms5394@cumc.columbia.edu   
United States, North Carolina
Wake Forest Not yet recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Stephen Peters, MD, PhD         
Contact: Marissa Millard    (336) 713-9190    mmillard@wakehealth.edu   
United States, Pennsylvania
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 10140
Contact: Gerald Criner, MD, FACP         
Contact: Keith Johnson    (215) 707-4547    keith.johnson@tuhs.temple.edu   
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84108
Contact: Paine Robert, MD         
Contact: Martin Villegas    (801) 581-6496    mvillegas@hsc.utah.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Columbia University
Johns Hopkins University
National Jewish Health
University of Alabama at Birmingham
University of California, Los Angeles
University of Illinois at Chicago
University of Iowa
University of Michigan
University of Utah
Wake Forest University Health Sciences
Temple University
University of California, San Francisco
COPD Foundation
Investigators
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Principal Investigator: Fernando J Martinez, MD, MS Weill Medical College at Cornell University
Principal Investigator: MeiLan K Han, MD,MS University of Michigan
Principal Investigator: Jeffrey L Curtis, MD University of Michigan
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT05033990    
Other Study ID Numbers: 21-06023662
R01HL144718 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No