Clinical trial NCT05033990: SPIROMICS Study of Early COPD Progression (SOURCE)
Official title: SPIROMICS Study of Early COPD Progression (SOURCE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD, Early-Onset
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of North Carolina, Chapel Hill
name: Columbia University
name: Johns Hopkins University
name: National Jewish Health
name: University of Alabama at Birmingham
name: University of California, Los Angeles
name: University of Illinois at Chicago
name: University of Iowa
name: University of Michigan
name: University of Utah
name: Wake Forest University Health Sciences
name: Temple University
name: University of California, San Francisco
name: COPD Foundation
name: Weill Medical College of Cornell University
name: Mayo Clinic
First posted: 2021-09-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: PRM fSAD
timeFrame: Year 2-5
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Fernando J Martinez, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: MeiLan K Han, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Jeffrey L Curtis, MD
role: PRINCIPAL_INVESTIGATOR
References: