Observational study on early COPD progression in smokers

SPIROMICS Study of Early COPD Progression (SOURCE)

This study is trying to see how early chronic obstructive pulmonary disease (COPD) develops in younger smokers by looking at their health and using scans and tests to find ways to help them sooner.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 30 Years to 55 Years
• Sex: All
• Sponsor: University of Massachusetts, Worcester (Academic / other)
• Drugs / interventions: radiation
• Locations: 14 sites (Birmingham, Alabama and 13 other locations)
• Trial ID: NCT05033990 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals by enrolling 1000 participants. The study will utilize CT scan imaging to identify smokers at risk of developing COPD, as well as investigate biomarkers and sputum analysis for predictive purposes. Participants will undergo comprehensive assessments including medical history questionnaires, pulmonary function testing, and various biospecimen collections. The goal is to enhance understanding of early COPD progression and identify potential early intervention strategies.

Who should consider this trial

Good fit: Ideal candidates include smokers aged 30-55 with varying degrees of COPD severity, as well as healthy controls with no significant smoking history.

Not a fit: Patients outside the age range of 30-55 or those with significant smoking history who do not meet the study's specific criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to early identification and intervention for individuals at risk of developing COPD, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using imaging and biomarkers for early COPD detection, indicating that this approach has potential based on previous findings.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* History of or current use of heroin.
* History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever.

Where this trial is running

Birmingham, Alabama and 13 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
• University of California Los Angeles — Los Angeles, California, United States (Recruiting)
• University of California, San Francisco — San Francisco, California, United States (Recruiting)
• National Jewish Health — Denver, Colorado, United States (Recruiting)
• University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
• University of Iowa — Iowa City, Iowa, United States (Recruiting)
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Columbia University — New York, New York, United States (Recruiting)
• Weill Cornell Medical Center — New York, New York, United States (Recruiting)
• Wake Forest — Winston-Salem, North Carolina, United States (Recruiting)
• Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Fernando J Martinez, MD, MS — University of Massachusetts, Worcester
• Study coordinator: Lori A Bateman, MS

Conditions COPD, Early-Onset