Study of Early COPD Progression in Younger At-Risk Smokers
Observes smokers aged 30 to 55 to learn who will develop early COPD.
Plain-language title generated from the registry record
Registry title: SPIROMICS Study of Early COPD Progression (SOURCE)
Key facts
- Where
- Ann Arbor, Baltimore, Birmingham, Chicago, Denver, Iowa City, Los Angeles, New York, Philadelphia, Salt Lake City, San Francisco, Scottsdale, and Winston-Salem, United StatesSee the 14 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 55 years old?
Source: NCT05033990, who can take part
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Johns Hopkins Bayview Medical CenterBaltimore, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- University of Illinois ChicagoChicago, United StatesTaking people
- National Jewish HealthDenver, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Columbia UniversityNew York, United StatesTaking people
- Weill Cornell Medical CenterNew York, United StatesTaking people
- Temple UniversityPhiladelphia, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Mayo Clinic - ArizonaScottsdale, United StatesTaking people
- Wake ForestWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Massachusetts, Worcester
- Trial code
- NCT05033990
- Record updated
- 3 June 2026
- Original description
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.Read full original descriptionShow less
SPIROMICS Study of Early COPD Progression (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.
Inclusion: 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: 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; 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; History of thoracic radiation or thoracic surgery with resection of lung tissue; Known HIV/AIDS infection; 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; 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; Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality; Current illicit substance abuse, excluding marijuana.