SPIROMICS Study of Early COPD Progression (SOURCE)
ConditionCOPD, Early-Onset
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-55
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 4 trial groupsGroup A: Healthy Controls
Group B: Gold 0
Group C: Preserved Ratio Impaired Spirometry (PRISm)
Group D: GOLD 1 - 2
Trial outcomes
Primary outcomes
1
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).
Time frame
Year 2-5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Columbia University
Collaborator
Johns Hopkins University
Collaborator
National Jewish Health
Collaborator
University of Alabama at Birmingham
Collaborator
University of California, Los Angeles
Collaborator
University of Illinois at Chicago
Collaborator
University of Iowa
Collaborator
University of Michigan
Collaborator
University of Utah
Collaborator
Wake Forest University Health Sciences
Collaborator
Temple University
Collaborator
University of California, San Francisco
Collaborator
COPD Foundation
Collaborator
Weill Medical College of Cornell University
Collaborator
Mayo Clinic
Collaborator
Source ClinicalTrials.gov