SPIROMICS Study of Early COPD Progression (SOURCE)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 30 Years to 55 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study follows 1,000 adults ages 30–55 to learn how COPD, a long-term lung disease, starts and gets worse. It uses lung CT scans, lab samples, and breathing tests to look for signs that predict which smokers will develop COPD. It includes people with a smoking history and a small group of healthy people who have not smoked.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 30–55 years old and meet the rules for one of the groups below.
- Healthy group: fewer than 100 cigarettes in your lifetime, no vaping or cannabis use, and breathing and symptom test scores within the study’s limits.
- Of the 40 healthy participants, 20 at selected sites must agree to an extra study using a scope to look inside the airways.
- All smoking-history groups: at least 10 pack-years of smoking, such as one pack a day for 10 years.
- GOLD 0 group: after medicine that opens the airways, breathing tests show an airflow ratio above 0.70 and air breathed out in one second above 80% of the expected amount.
- PRISm group: after airway-opening medicine, the airflow ratio is above 0.70, but air breathed out in one second is below 80% of the expected amount.
- GOLD 1–2 group: after airway-opening medicine, the airflow ratio is below 0.70 and air breathed out in one second is above 50% of the expected amount.
Who can't join
- Severe asthma: certain higher-level asthma treatments, three or more unplanned asthma care visits in the past year, or a hospital stay for asthma in the past year.
- Taking part in another treatment study where the treatment being given is kept hidden.
- Pregnant at the first visit or planning pregnancy during the study; or problems with thinking or memory that prevent completing study tasks.
- Body mass index (BMI), a measure based on height and weight, above 35 at the first visit; or metal implants above the waist that could affect lung CT images.
- Another lung condition besides COPD or asthma, or another health problem that the study doctor thinks is the main cause of breathing symptoms.
- An illness expected to cause death within three years, or known HIV/AIDS.
- Past radiation treatment to the chest or chest surgery that removed lung tissue.
- Current illegal drug abuse, except marijuana; any past or current heroin use or Ritalin use by injection; or illegal drug injection in the past 10 years or more than five times ever.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (14)
AL
- University of Alabama at Birmingham · Birmingham, AL 35205J. Michael Wells, MD · Study contact · itis-lhc@uab.eduMichelle Williams · Study contact · (205) 934-5555 · itis-lhc@uab.eduJ. Michael Wells, MD · Principal investigatorMore trials in Birmingham
AZ
- Mayo Clinic Arizona · Scottsdale, AZ 85259Victor Ortega, MD, PhD · Study contactTemeka Simmons · Study contact · (480) 301-9224 · Simmons.Temeka@mayo.eduVictor Ortega, MD · Principal investigatorMore trials in Scottsdale
CA
- University of California Los Angeles · Los Angeles, CA 90095Igor Barjaktarevic, MD, PhD · Study contactRoslynn Marzan-McGill, CPT, CCRP · Study contact · (310) 825-2616 · rmcgill@mednet.ucla.eduIgor Barjaktarevic, MD, PhD · Principal investigatorMore trials in Los Angeles
- University of California, San Francisco · San Francisco, CA 94143Prescott G. Woodruff, MD, MPH · Study contact · 415-479-3370 · prescott.woodruff@ucsf.eduDevin Roberts · Study contact · (628) 233-1233 · source@ucsf.eduPrescott G. Woodruff, MD, MPH · Principal investigatorMore trials in San Francisco
CO
- National Jewish Health · Denver, CO 80206Claudia Onofrei, MD · Study contactGrace Wessels · Study contact · (303) 270-2418 · copdresearch@njhealth.orgClaudia Onofrei, MD · Principal investigatorMore trials in Denver
IA
- University of Iowa · Iowa City, IA 52242Alejandro Comellas, MD · Study contactRimas Nemickas · Study contact · (319) 353-8863 · rimas-nemickas@uiowa.eduAlejandro Comellas, MD · Principal investigatorMore trials in Iowa City
IL
- University of Illinois Chicago · Chicago, IL 60608Jerry Krishnan, MD, PhD · Study contactLauren Greene · Study contact · (312) 996-1365 · source_study@uic.eduJerry Krishnan, MD, PhD · Principal investigatorMore trials in Chicago
MD
- Johns Hopkins Bayview Medical Center · Baltimore, MD 21224Nadia Hansel, MD, MPH · Study contactWendy Lorizio · Study contact · (410) 550-2449 · wlorizi1@jhmi.eduNadia Hansel, MD, MPH · Principal investigatorMore trials in Baltimore
MI
- University of Michigan · Ann Arbor, MI 48130Meilan Han, MD, MPH · Study contact · mrking@med.umich.eduCrystal Cutlip · Study contact · (734) 647-6399 · MI-SOURCE@med.umich.eduMeilan Han, MD, MPH · Principal investigatorMore trials in Ann Arbor
NC
- Wake Forest · Winston-Salem, NC 27104Jessica Bon, MD · Study contactAshlynn Brock · Study contact · (336) 713-8550 · abrock@wakehealth.eduJessica Bon, MD · Principal investigatorMore trials in Winston-Salem
NY
- Columbia University · New York, NY 10032R. Graham Barr, MD, PhD · Study contactRamaz Elsadig · Study contact · (646) 859-9553 · re2412@cumc.columbia.eduR. Graham Barr, MD, PhD · Principal investigatorMore trials in New York
- Weill Cornell Medical Center · New York, NY 10065Robert J Kaner, MD · Study contact · rkaner@med.cornell.eduKimberly Kerr · Study contact · (646) 962-2730 · pulmonaryresearch@med.cornell.eduRobert Kaner, MD · Principal investigatorMore trials in New York
PA
- Temple University · Philadelphia, PA 10140Nathaniel Marchetti, DO · Study contactSheril George · Study contact · (215) 707-1359 · breathe@tuhs.temple.eduNathaniel Marchetti, DO · Principal investigatorMore trials in Philadelphia
UT
- University of Utah · Salt Lake City, UT 84108Robert Paine, MD · Study contactMartin Villegas · Study contact · (801) 581-6496 · mvillegas@hsc.utah.eduRobert Paine, MD · Principal investigatorMore trials in Salt Lake City