Actively Recruiting

Age: 30Years - 55Years
All Genders
Healthy Volunteers
NCT05033990

SPIROMICS Study of Early COPD Progression (SOURCE)

Led by University of Massachusetts, Worcester · Updated on 2025-05-29

1000

Participants Needed

14

Research Sites

238 weeks

Total Duration

On this page

Sponsors

U

University of Massachusetts, Worcester

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SPIROMICS Study of Early COPD Progression (SOURCE)

Who Can Participate

Age: 30Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 30 to 55 years
  • Healthy controls with no significant smoking history (<100 cigarettes lifetime), normal lung function, and low airway symptom scores
  • Participants with ≥10 pack-year smoking history categorized as GOLD 0, PRISm, or GOLD 1-2 based on lung function
  • Willingness to provide samples and undergo lung function testing and CT imaging
  • Some healthy controls willing to participate in a bronchoscopy sub-study
Not Eligible

You will not qualify if you...

  • Severe asthma requiring high-level treatment or frequent healthcare visits/hospitalization in past 12 months
  • Participation in a blinded therapeutic clinical trial
  • Current pregnancy or planning pregnancy during the study
  • Cognitive dysfunction preventing study participation
  • BMI over 35 kg/m2
  • Presence of lung diseases other than COPD or significant comorbid conditions causing respiratory symptoms
  • Illness expected to cause death within 3 years
  • Implanted metal devices or prostheses above the waist affecting CT imaging
  • History of thoracic radiation or lung surgery
  • Known HIV/AIDS infection
  • Current illicit substance abuse (excluding marijuana)
  • History or current use of IV Ritalin or heroin
  • History of illegal IV drug use within the last 10 years or more than 5 instances ever

AI-Screening

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Trial Site Locations

Total: 14 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

Mayo Clinic Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

3

University of California Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

4

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

5

National Jewish Health

Denver, Colorado, United States, 80206

Actively Recruiting

6

University of Illinois Chicago

Chicago, Illinois, United States, 60608

Actively Recruiting

7

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

8

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21224

Actively Recruiting

9

University of Michigan

Ann Arbor, Michigan, United States, 48130

Actively Recruiting

10

Columbia University

New York, New York, United States, 10032

Actively Recruiting

11

Weill Cornell Medical Center

New York, New York, United States, 10065

Actively Recruiting

12

Wake Forest

Winston-Salem, North Carolina, United States, 27104

Actively Recruiting

13

Temple University

Philadelphia, Pennsylvania, United States, 10140

Actively Recruiting

14

University of Utah

Salt Lake City, Utah, United States, 84108

Actively Recruiting

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Research Team

L

Lori A Bateman, MS

CONTACT

D

David Couper, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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SPIROMICS Study of Early COPD Progression (SOURCE) | DecenTrialz