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SPIROMICS Study of Early COPD Progression (SOURCE)

University of Massachusetts, Worcester · with National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill · NCT05033990

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–55 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1000
US sites recruiting
14
Study start
September 8, 2021
Record last updated
June 3, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This is an observational study of 1000 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.

Conditions: COPD, Early-Onset

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 40 of the 1000 will be healthy controls: ages 30-55 years; with no smoking history (\< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator FEV1/FVC > 0.70; pre-bronchodilator FEV1 > 80% predicted; pre-bronchodilator FVC > 80% predicted; Chronic Airway Assessment Test (CAAT) score \< 10. Willingness to also participate in the bronchoscopy sub-study is only required of the 20 healthy controls recruited from the clinical centers participating in the sub-study.
  • 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

  • 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 (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.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35205

    Site contact: J. Michael Wells, MD · itis-lhc@uab.edu

  • Mayo Clinic Arizona

    Scottsdale, AZ 85259

    Site contact: Victor Ortega, MD, PhD

  • University of California Los Angeles

    Los Angeles, CA 90095

    Site contact: Igor Barjaktarevic, MD, PhD

  • University of California, San Francisco

    San Francisco, CA 94143

    Site contact: Prescott G. Woodruff, MD, MPH · 415-479-3370 · prescott.woodruff@ucsf.edu

  • National Jewish Health

    Denver, CO 80206

    Site contact: Claudia Onofrei, MD

  • University of Illinois Chicago

    Chicago, IL 60608

    Site contact: Jerry Krishnan, MD, PhD

  • University of Iowa

    Iowa City, IA 52242

    Site contact: Alejandro Comellas, MD

  • Johns Hopkins Bayview Medical Center

    Baltimore, MD 21224

    Site contact: Nadia Hansel, MD, MPH

  • University of Michigan

    Ann Arbor, MI 48130

    Site contact: Meilan Han, MD, MPH · mrking@med.umich.edu

  • Columbia University

    New York, NY 10032

    Site contact: R. Graham Barr, MD, PhD

  • Weill Cornell Medical Center

    New York, NY 10065

    Site contact: Robert J Kaner, MD · rkaner@med.cornell.edu

  • Wake Forest

    Winston-Salem, NC 27104

    Site contact: Jessica Bon, MD

  • Temple University

    Philadelphia, PA 10140

    Site contact: Nathaniel Marchetti, DO

  • University of Utah

    Salt Lake City, UT 84108

    Site contact: Robert Paine, MD

Study contacts (from the official record)

  • Lori A Bateman, MS · 9199623266 · lbateman@email.unc.edu
  • David Couper, PhD · 9199623229 · david_couper@unc.edu
SPIROMICS Study of Early COPD Progression (SOURCE) (NCT05033990) | Bored Studies