SPIROMICS Study of Early COPD Progression (SOURCE)

NCT05033990 | Recruiting DMC

• 2 other identifiers: STUDY00002081R01HL144718
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

Brief Summary

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

COPD, Early-Onset

Outcome Measures

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).

  Year 2-5

Study Arms (4)

Healthy Controls

Participants 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.

Gold 0

Participants 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.

Preserved Ratio Impaired Spirometry (PRISm)

Participants with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 \< 80% predicted.

GOLD 1 - 2

Participants graded as GOLD 0 by the GOLD grading system: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 ≥ 50% predicted.

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.
• History of thoracic radiation or thoracic surgery with resection of lung tissue.
• Known HIV/AIDS infection.
• Current illicit substance abuse, excluding marijuana.
• History of or current use of IV Ritalin.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• 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

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60608, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48130, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Wake Forest

Winston-Salem, North Carolina, 27104, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 10140, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, RNA, DNA, exhaled breath condensate, nasal swab, sputum, urine, and stool samples will be collected. A subset of participant will undergo bronchoscopy to collect sample such as bronchoalveolar lavage and large and small airway brushings.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando J Martinez, MD, MS

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

• MeiLan K Han, MD,MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Jeffrey L Curtis, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori A Bateman, MS

CONTACT

9199623266; lbateman@email.unc.edu

David Couper, PhD

CONTACT

9199623229; david_couper@unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: September 8, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)