Recruiting

COPDSPIROMICS Study of Early COPD Progression (SOURCE)

Sponsor:

University of Massachusetts, Worcester

Code:

NCT05033990

Conditions

COPD, Early-Onset

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Study ID

NCT05033990

Start date

Sep 8, 2021

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

PRM fSAD [ Time Frame: Year 2-5 ]

Central Contacts and Locations

Central contacts

Lori A Bateman, MS

9199623266 lbateman@email.unc.edu

David Couper, PhD

9199623229 david_couper@unc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

J. Michael Wells, MD

itis-lhc@uab.edu

Michelle Williams

(205) 934-5555 itis-lhc@uab.edu

Principal Investigator:

J. Michael Wells, MD

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Temeka Simmons

(480) 301-9224 Simmons.Temeka@mayo.edu

Principal Investigator:

Victor Ortega, MD

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Roslynn Marzan-McGill, CPT, CCRP

(310) 825-2616 rmcgill@mednet.ucla.edu

Principal Investigator:

Igor Barjaktarevic, MD, PhD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Prescott G. Woodruff, MD, MPH

415-479-3370 prescott.woodruff@ucsf.edu

Devin Roberts

(628) 233-1233 source@ucsf.edu

Principal Investigator:

Prescott G. Woodruff, MD, MPH

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Grace Wessels

(303) 270-2418 copdresearch@njhealth.org

Principal Investigator:

Claudia Onofrei, MD

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Lauren Greene

(312) 996-1365 source_study@uic.edu

Principal Investigator:

Jerry Krishnan, MD, PhD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Rimas Nemickas

(319) 353-8863 rimas-nemickas@uiowa.edu

Principal Investigator:

Alejandro Comellas, MD

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Wendy Lorizio

(410) 550-2449 wlorizi1@jhmi.edu

Principal Investigator:

Nadia Hansel, MD, MPH

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48130

Contacts

Meilan Han, MD, MPH

mrking@med.umich.edu

Crystal Cutlip

(734) 647-6399 MI-SOURCE@med.umich.edu

Principal Investigator:

Meilan Han, MD, MPH

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Ramaz Elsadig

(646) 859-9553 re2412@cumc.columbia.edu

Principal Investigator:

R. Graham Barr, MD, PhD

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Robert J Kaner, MD

rkaner@med.cornell.edu

Kimberly Kerr

(646) 962-2730 pulmonaryresearch@med.cornell.edu

Principal Investigator:

Robert Kaner, MD

Wake Forest

Recruiting

Winston-Salem, North Carolina, United States, 27104

Contacts

Ashlynn Brock

(336) 713-8550 abrock@wakehealth.edu

Principal Investigator:

Jessica Bon, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 10140

Contacts

Sheril George

(215) 707-1359 breathe@tuhs.temple.edu

Principal Investigator:

Nathaniel Marchetti, DO

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Martin Villegas

(801) 581-6496 mvillegas@hsc.utah.edu

Principal Investigator:

Robert Paine, MD

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-06-03.