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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD, Early-Onset

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Lori A Bateman, MS; Phone Number: 9199623266; Email: lbateman@email.unc.edu
• Study Contact Backup: Name: David Couper, PhD; Phone Number: 9199623229; Email: david_couper@unc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Michelle Williams; Phone Number: (205) 934-5555; Email: itis-lhc@uab.edu
      • Contact: J. Michael Wells, MD; Email: itis-lhc@uab.edu
      • Principal Investigator: J. Michael Wells, MD
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Victor Ortega, MD, PhD
      • Principal Investigator: Victor Ortega, MD
      • Contact: Temeka Simmons; Phone Number: (480) 301-9224; Email: Simmons.Temeka@mayo.edu
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Contact: Igor Barjaktarevic, MD, PhD
      • Contact: Roslynn Marzan-McGill, CPT, CCRP; Phone Number: (310) 825-2616; Email: rmcgill@mednet.ucla.edu
      • Principal Investigator: Igor Barjaktarevic, MD, PhD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Prescott G. Woodruff, MD, MPH; Phone Number: 415-479-3370; Email: prescott.woodruff@ucsf.edu
      • Principal Investigator: Prescott G. Woodruff, MD, MPH
      • Contact: Devin Roberts; Phone Number: (628) 233-1233; Email: source@ucsf.edu
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
      • Contact: Claudia Onofrei, MD
      • Contact: Grace Wessels; Phone Number: (303) 270-2418; Email: copdresearch@njhealth.org
      • Principal Investigator: Claudia Onofrei, MD
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • University of Illinois Chicago
      • Principal Investigator: Jerry Krishnan, MD, PhD
      • Contact: Jerry Krishnan, MD, PhD
      • Contact: Lauren Greene; Phone Number: (312) 996-1365; Email: source_study@uic.edu
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Alejandro Comellas, MD
      • Principal Investigator: Alejandro Comellas, MD
      • Contact: Rimas Nemickas; Phone Number: (319) 353-8863; Email: rimas-nemickas@uiowa.edu
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Principal Investigator: Nadia Hansel, MD, MPH
      • Contact: Nadia Hansel, MD, MPH
      • Contact: Wendy Lorizio; Phone Number: (410) 550-2449; Email: wlorizi1@jhmi.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48130
      • Recruiting
      • University of Michigan
      • Contact: Meilan Han, MD, MPH; Email: mrking@med.umich.edu
      • Principal Investigator: Meilan Han, MD, MPH
      • Contact: Crystal Cutlip; Phone Number: (734) 647-6399; Email: MI-SOURCE@med.umich.edu
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: R. Graham Barr, MD, PhD
      • Contact: Ramaz Elsadig; Phone Number: (646) 859-9553; Email: re2412@cumc.columbia.edu
      • Principal Investigator: R. Graham Barr, MD, PhD
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical Center
      • Principal Investigator: Robert Kaner, MD
      • Contact: Robert J Kaner, MD; Email: rkaner@med.cornell.edu
      • Contact: Kimberly Kerr; Phone Number: (646) 962-2730; Email: pulmonaryresearch@med.cornell.edu
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Recruiting
      • Wake Forest
      • Contact: Jessica Bon, MD
      • Contact: Ashlynn Brock; Phone Number: (336) 713-8550; Email: abrock@wakehealth.edu
      • Principal Investigator: Jessica Bon, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 10140
      • Recruiting
      • Temple University
      • Principal Investigator: Nathaniel Marchetti, DO
      • Contact: Sheril George; Phone Number: (215) 707-1359; Email: breathe@tuhs.temple.edu
      • Contact: Nathaniel Marchetti, DO
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah
      • Contact: Martin Villegas; Phone Number: (801) 581-6496; Email: mvillegas@hsc.utah.edu
      • Contact: Robert Paine, MD
      • Principal Investigator: Robert Paine, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

14 clinical centers across the US will enroll a total of 1000 participants, 30-55 years old, both sexes, all races, and all ethnicities. The participants will include never-smokers (n=40) and GOLD stage 0-2 participants (n=960).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.
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 ≥ 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% predicted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRM fSAD	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).	Year 2-5

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Johns Hopkins University; Mayo Clinic; National Heart, Lung, and Blood Institute (NHLBI); University of California, Los Angeles; University of Alabama at Birmingham; Columbia University; University of Michigan; University of Iowa; University of Illinois at Chicago; Weill Medical College of Cornell University; Wake Forest University Health Sciences; University of California, San Francisco; University of North Carolina, Chapel Hill; Temple University; University of Utah; National Jewish Health; COPD Foundation
• Investigators: Principal Investigator: MeiLan K Han, MD,MS, University of Michigan; Principal Investigator: Jeffrey L Curtis, MD, University of Michigan; Principal Investigator: Fernando J Martinez, MD, MS, University of Massachusetts Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002081; R01HL144718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No