Early Progression Study for COPD

(SOURCE Trial)

Recruiting at 13 trial locations

Overseen By David Couper, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must not be taking: High-dose inhalers

Disqualifiers: Severe asthma, Pregnancy, Cognitive dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand early chronic obstructive pulmonary disease (COPD) in individuals who might be at risk. Researchers seek to identify which smokers are likely to develop COPD by analyzing lung images, biomarkers (body indicators), and sputum (phlegm) samples. Participants will undergo various assessments, including CT imaging of the lungs, pulmonary function testing, and sample collections such as nasal swab, blood, stool, and urine samples. Smokers with a history of 10 or more pack years are suitable candidates, provided they do not have severe asthma or other major lung conditions.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to early detection and prevention strategies for COPD.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the SPIROMICS Study because it aims to uncover new insights into early COPD progression using advanced diagnostic techniques. Unlike traditional methods that mainly focus on managing symptoms, this study uses a combination of CT imaging, various biological samples, and pulmonary function testing to get a deeper understanding of the disease. By collecting and analyzing data from these diverse sources, researchers hope to identify early markers of COPD and potentially develop more targeted interventions in the future. This comprehensive approach could lead to breakthroughs in early detection and personalized treatment plans for COPD patients.

Who Is on the Research Team?

Fernando J Martinez, MD, MS

Principal Investigator

University of Massachusetts Chan Medical School

MeiLan K Han, MD,MS

Principal Investigator

University of Michigan

Jeffrey L Curtis, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

20 of the 600 will be healthy controls: ages 30-55 years; with no smoking history (< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 0.70; pre-bronchodilator FEV1 ≥ 80% predicted; pre-bronchodilator FVC ≥ 80% predicted; and willingness to also participate in the bronchoscopy sub-study.

Approximately one-third of the 580 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. This early COPD group has been chosen because it is not currently well-represented in COPDGene and SPIROMICS cohorts.

Approximately one-third of the 580 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. This early COPD group was enrolled in small numbers in the COPDGene study, but was excluded from SPIROMICS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

Participants undergo questionnaires, provide samples, and receive CT imaging to assess early COPD progression

2-5 years

Follow-up

Participants are monitored for changes in lung function and COPD progression

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CT imaging of the lungs
• Nasal swab, blood, stool, and urine samples
• Pulmonary function testing
• Sputum induction
• Study-related questionnaires

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+