SPIROMICS Study of Early COPD Progression (SOURCE)

COPD, Early-Onset Clinical Trial

— SOURCE  

Official title:

SPIROMICS Study of Early COPD Progression (SOURCE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033990
• Other study ID #: 22-07025024
• Secondary ID: R01HL144718
• Status: Recruiting
• Start date: September 8, 2021
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Lori A Bateman, MS
• Phone: 9199623266
• Email: lbateman[@]email.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD, Early-Onset

Locations

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

Sponsors (17)

Lead Sponsor

Collaborator

Weill Medical College of Cornell University

Columbia University, COPD Foundation, Johns Hopkins University, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), National Jewish Health, Temple University, University of Alabama at Birmingham, University of California, Los Angeles, University of California, San Francisco, University of Illinois at Chicago, University of Iowa, University of Michigan, University of North Carolina, Chapel Hill, University of Utah, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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