Summary

Eligibility
for people ages 30-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Prescott G. Woodruff, MD, MPH
Headshot of Prescott G. Woodruff
Prescott G. Woodruff

Description

Summary

This is an observational study of 600 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.

Keywords

COPD, Early-Onset Gold 0 Preserved Ratio Impaired Spirometry (PRISm) Gold 1 - 2

Eligibility

You can join if…

Open to people ages 30-55

  • 20 of the 600 will be healthy controls: ages 30-55 years; with no smoking history (< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 0.70; pre-bronchodilator FEV1 ≥ 80% predicted; pre-bronchodilator FVC ≥ 80% predicted; and willingness to also participate in the bronchoscopy sub-study.
  • Approximately one-third of the 580 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. This early COPD group has been chosen because it is not currently well-represented in COPDGene and SPIROMICS cohorts.
  • Approximately one-third of the 580 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. This early COPD group was enrolled in small numbers in the COPDGene study, but was excluded from SPIROMICS.
  • Approximately one-third of the 580 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. This early COPD group has been chosen because it is also not currently well-represented in the first funded phase of the COPDGene and SPIROMICS cohorts.

You CAN'T join 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/m2 at baseline, due to the effects of body weight on CT scan imaging quality.

  • The presence of a respiratory condition other than COPD or asthma, 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.

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • University of California Los Angeles not yet accepting patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

  • Prescott G. Woodruff, MD, MPH
    I. Mentoring in Translational Research II. The identification of molecular sub-phenotypes of asthma and COPD III. Mechanisms of airway inflammation and remodeling in lung diseases IV. Development of blood-based diagnostic tests for lung disease using genomic approaches V. Clinical Trials in asthma and COPD

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Weill Medical College of Cornell University
ID
NCT05033990
Study Type
Observational
Participants
Expecting 600 study participants
Last Updated