COPD, Early-OnsetSOURCENCT05033990
SPIROMICS Study of Early COPD Progression (SOURCE)
An observational study of COPD, Early-Onset, run by University of Massachusetts, Worcester at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Early-Onset
- How many people
- 1,000 participants
- Where
- 14 sitesUnited States
- Study dates
- 8 Sep 2021to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48130
Meilan Han, MD, MPH, mrking@med.umich.edu
Crystal Cutlip, (734) 647-6399, MI-SOURCE@med.umich.edu
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Nadia Hansel, MD, MPH
Wendy Lorizio, (410) 550-2449, wlorizi1@jhmi.edu
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
J. Michael Wells, MD, itis-lhc@uab.edu
Michelle Williams, (205) 934-5555, itis-lhc@uab.edu
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60608
Jerry Krishnan, MD, PhD
Lauren Greene, (312) 996-1365, source_study@uic.edu
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Claudia Onofrei, MD
Grace Wessels, (303) 270-2418, copdresearch@njhealth.org
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Alejandro Comellas, MD
Rimas Nemickas, (319) 353-8863, rimas-nemickas@uiowa.edu
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Igor Barjaktarevic, MD, PhD
Roslynn Marzan-McGill, CPT, CCRP, (310) 825-2616, rmcgill@mednet.ucla.edu
- Recruiting
Columbia University
New York, New York, 10032
R. Graham Barr, MD, PhD
Ramaz Elsadig, (646) 859-9553, re2412@cumc.columbia.edu
- Recruiting
Weill Cornell Medical Center
New York, New York, 10065
Robert J Kaner, MD, rkaner@med.cornell.edu
Kimberly Kerr, (646) 962-2730, pulmonaryresearch@med.cornell.edu
- Recruiting
Temple University
Philadelphia, Pennsylvania, 10140
Nathaniel Marchetti, DO
Sheril George, (215) 707-1359, breathe@tuhs.temple.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Robert Paine, MD
Martin Villegas, (801) 581-6496, mvillegas@hsc.utah.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Prescott G. Woodruff, MD, MPH, 415-479-3370, prescott.woodruff@ucsf.edu
Devin Roberts, (628) 233-1233, source@ucsf.edu
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Victor Ortega, MD, PhD
Temeka Simmons, (480) 301-9224, Simmons.Temeka@mayo.edu
- Recruiting
Wake Forest
Winston-Salem, North Carolina, 27104
Jessica Bon, MD
Ashlynn Brock, (336) 713-8550, abrock@wakehealth.edu
About this study
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:
Read more
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Year 2-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start8 Sep 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD, Early-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- 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 Chicago, University of Iowa, University of Michigan, University of Utah, Wake Forest University Health Sciences, Temple University, University of California, San Francisco, COPD Foundation, Weill Medical College of Cornell University, Mayo Clinic
- Responsible party
- Principal investigator, Fernando J Martinez, University of Massachusetts, Worcester
- Investigators
- Fernando J Martinez, MD, MS, Principal investigator, University of Massachusetts, WorcesterMeiLan K Han, MD,MS, Principal investigator, University of MichiganJeffrey L Curtis, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033990
- Sponsor's protocol ID
- STUDY00002081
- Other IDs
- R01HL144718
- Acronym
- SOURCE
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIROMICS Study of Early COPD Progression (SOURCE)
- ClinicalTrials.gov ID
- NCT05033990
- Acronym / sponsor ID
- SOURCE / STUDY00002081
- Conditions
- COPD, Early-Onset
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- 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 Chicago, University of Iowa, University of Michigan, University of Utah, Wake Forest University Health Sciences, Temple University, University of California, San Francisco, COPD Foundation, Weill Medical College of Cornell University, Mayo Clinic
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- Severe asthma, which is defined as any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando J Martinez, MD, MS principal investigator
University of Massachusetts, Worcester
MeiLan K Han, MD,MS principal investigator
University of Michigan
Jeffrey L Curtis, MD principal investigator
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, Early-Onset, run by University of Massachusetts, Worcester at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori A Bateman, MS (9199623266, lbateman@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRM fSAD (time frame: Year 2-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.