Study of COPD Subgroups and Biomarkers

NCT01969344 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2981

Last updated 2025-11-13

No results posted yet for this study

Summary

SPIROMICS I, SPIROMICS II, and SPIROMICS III are longitudinal observational studies of Chronic Obstructive Pulmonary Disease (COPD) cohort.

SPIROMICS I had two primary aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and to provide new ways of testing whether a new treatment is working.

SPIROMICS II had three primary aims: (1) To define the natural history of "smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition; (2) To determine the radiographic precursor lesion(s) for emphysema and identify the molecular phenotypes underlying airway disease and emphysema; (3) To advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.

SPIROMICS III has three primary aims: (1) To identify the main forms of smoking-related airway disease that are caused by pathological airway mucus, their biological underpinnings, and their physiological significance; (2) To identify longitudinal trajectories in established and novel CT measures of emphysema, test how they predict COPD progression, and define their underlying biology; (3) To identify environmental and social determinants of health that impact disease severity and progression and their influence on lung structure, biology, and health disparities in COPD.

Conditions

Sponsors & Collaborators

Principal Investigators

  • David Couper, PhD · University of North Carolina, Chapel Hill

  • Graham Barr, PhD, MD · Columbia University

  • Robert Paine, MD · University of Utah

  • Eric Hoffman, MD · University of Iowa

  • Prescott Woodruff, MD · University of California at San Francisco

  • Igor Barjaktarevic, MD · University of California at Los Angeles

  • MeiLan Han, MD · University of Michigan

  • Claudia Onofrei, MD, MSc · National Jewish Health

  • Alejandro Cornellas, MD · University of Iowa

  • Nathaniel Marchetti, DO · Temple University

  • J. Michael Wells, MD · University of Alabama at Birmingham

  • Nadia Hansel, MD · Johns Hopkins University

  • Jerry Krishnan, MD · University of Illinois at Chicago

  • Jessica Bon, MD, MS, ATSF · Wake Forest University

  • Robert Kaner, MD · Weill Medical College of Cornell University

  • Victor Ortega, MD, PhD · Mayo Clinic

  • Christopher Cooper, MD, PhD · University of California at Los Angeles

  • Neil Alexis, PhD · University of North Carolina, Chapel Hill

  • Sanjiv Shah · Northwestern University

  • Joao Lima, MD, MBA · Johns Hopkins University

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2031-06-17
Completion
2031-06-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969344 on ClinicalTrials.gov