SPIROMICS Study of Early COPD Progression (SOURCE)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Massachusetts, Worcester
- Study ID
- NCT05033990
- Status
- Recruiting
Conditions
- COPD, Early-Onset
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 55 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Sep 8, 2021
- Status verified
- Jun 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Healthy ControlsParticipants 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.
- Arm: Gold 0Participants 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.
- Arm: Preserved Ratio Impaired Spirometry (PRISm)Participants with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 \< 80% predicted.
- Arm: GOLD 1 - 2Participants 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
- Lori A Bateman, MS9199623266
- David Couper, PhD9199623229
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | J. Michael Wells, MD J. Michael Wells, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | Victor Ortega, MD, PhD Victor Ortega, MD (PRINCIPAL_INVESTIGATOR) |
| University of California Los Angeles | Los Angeles | California | 90095 | Igor Barjaktarevic, MD, PhD Igor Barjaktarevic, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Prescott G. Woodruff, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| National Jewish Health | Denver | Colorado | 80206 | Claudia Onofrei, MD Claudia Onofrei, MD (PRINCIPAL_INVESTIGATOR) |
| University of Illinois Chicago | Chicago | Illinois | 60608 | Jerry Krishnan, MD, PhD Jerry Krishnan, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Iowa | Iowa City | Iowa | 52242 | Alejandro Comellas, MD Alejandro Comellas, MD (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | Nadia Hansel, MD, MPH Nadia Hansel, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48130 | Meilan Han, MD, MPH Meilan Han, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | R. Graham Barr, MD, PhD R. Graham Barr, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medical Center | New York | New York | 10065 | Robert J Kaner, MD Robert Kaner, MD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest | Winston-Salem | North Carolina | 27104 | Jessica Bon, MD Jessica Bon, MD (PRINCIPAL_INVESTIGATOR) |
| Temple University | Philadelphia | Pennsylvania | 10140 | Nathaniel Marchetti, DO Nathaniel Marchetti, DO (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84108 | Robert Paine, MD Robert Paine, MD (PRINCIPAL_INVESTIGATOR) |