Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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SPIROMICS Study of Early COPD Progression (SOURCE)

Status: Recruiting
Location: See all (14) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Mayo Clinic Arizona
RECRUITING
Scottsdale
California
University of California Los Angeles
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Colorado
National Jewish Health
RECRUITING
Denver
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
University of Illinois Chicago
RECRUITING
Chicago
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
Wake Forest
RECRUITING
Winston-salem
New York
Columbia University
RECRUITING
New York
Weill Cornell Medical Center
RECRUITING
New York
Pennsylvania
Temple University
RECRUITING
Philadelphia
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Lori A Bateman, MS
lbateman@email.unc.edu
9199623266
Backup
David Couper, PhD
david_couper@unc.edu
9199623229
Time Frame
Start Date: 2021-09-08
Estimated Completion Date: 2026-04
Participants
Target number of participants: 1000
Treatments
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.
Sponsors
Collaborators: Mayo Clinic, Weill Medical College of Cornell University, University of Michigan, National Jewish Health, National Heart, Lung, and Blood Institute (NHLBI), Columbia University, Temple University, University of Iowa, Wake Forest University Health Sciences, University of Utah, Johns Hopkins University, University of Alabama at Birmingham, COPD Foundation, University of Illinois at Chicago, University of California, Los Angeles, University of California, San Francisco, University of North Carolina, Chapel Hill
Leads: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov