Study of COPD Subgroups and Biomarkers

Running, not enrolling

Conditions studied: COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema

In brief

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.

Key facts

Study ID

NCT01969344

Run by

University of North Carolina, Chapel Hill

People needed

2981

Starts

2010-11-01

Expected to finish

2031-06-17

Last updated by the study team

2025-11-13

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Between 40 and 80 at baseline visit
• Never smokers: <1 pack-year history of smoking
• Never smokers: Must meet lung function criteria based on spirometry without inhaled bronchodilators
• Current or former smokers: >20 pack-year history of smoking
• Current or former smokers: Must meet lung function criteria based on spirometry with inhaled bronchodilators

You may not qualify if…

• Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
• Plans to leave the area in the next 3 years
• Smoking history of > 1 pack-year but <21 pack-years
• BMI > 40 kg/m2 at baseline exam
• Prior significant difficulties with pulmonary function testing
• Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers
• Non-COPD obstructive lung disease, severe kyphoscoliosis, neuromuscular weakness, or other conditions, including clinically significant cardiovascular and pulmonary disease, that, limit the interpretability of the pulmonary function measures.
• History of Interstitial lung disease
• History of Lung volume reduction surgery or lung resection
• History of lung or other organ transplant
• History of endobronchial valve therapy
• History of large thoracic metal implants (e.g., AICD (automatic implantable cardioverter/defibrillator) and/or pacemaker)
• Currently taking >=10mg a day/20mg every other day of prednisone or equivalent systemic corticosteroid
• Currently taking any immunosuppressive agent
• 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
• Known HIV/AIDS infection
• History of lung cancer or any cancer that spread to multiple locations in the body
• History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
• Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
• Any illness expected to cause mortality in the next 3 years
• Active pulmonary infection, including tuberculosis
• History of pulmonary embolism in the past 2 years

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.