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NCT01969344Active, not recruiting

Study of COPD Subgroups and Biomarkers

Subpopulations and Intermediate Outcome Measures in COPD Study

Source: ClinicalTrials.gov · Last updated 13 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2981 (actual)
First submitted
16 Oct 2013
Start date
Nov 2010
Primary completion date
17 Jun 2031
Lead sponsor
University of North Carolina, Chapel Hill
Diseases
COPD
NCT number
NCT01969344

What you commit to

  • Study type: Observational
  • Participants enrolled: 2981
  • From Nov 2010 to the primary completion date, 17 Jun 2031
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior significant difficulties with pulmonary function testing
  • Currently taking \>=10mg a day/20mg every other day of prednisone or equivalent systemic corticosteroid
  • Currently taking any immunosuppressive agent
  • Participants who present with current use of acute antibiotics or steroids can complete the study visit ≥30 days after discontinuing acute antibiotics/steroids. This does not apply to participants who are on chronic prednisone therapy of \<10 mg per day or \<20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.

Other illness

  • 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
  • Smoking history of \> 1 pack-year but \<21 pack-years
  • 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)
  • 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
  • Participants who present with an upper respiratory infection, either solely participant-identified or that has been clinically treated, in the last six weeks, can complete the study visit once a six-week window has passed.
  • Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks can complete the study visit after a six-week window has passed.

Other

  • Plans to leave the area in the next 3 years
  • BMI \> 40 kg/m2 at baseline exam
  • Current illicit substance abuse, excluding marijuana
  • Known diagnosis of primary bronchiectasis
  • Currently institutionalized (e.g., prisons, long-term care facilities)
  • Known to be a first degree relative of another, already enrolled participant (i.e., biological parent, biological sibling)
  • Never smokers only: Current diagnosis of asthma
  • Women only: Cannot be pregnant at baseline or plan to become pregnant during the course of the study
    • Temporal Exclusion Criteria for SPIROMICS III:
  • Participants who present with a pulmonary exacerbation, either solely participant-identified or that has been clinically treated, in the last six weeks, can complete the study visit once a six-week window has passed.
  • Female participants who present \<3 months after giving birth will be asked to schedule the visit once three months have passed post-delivery.

Who the study is looking for

  • 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

Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Johns Hopkins University
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of Illinois at Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
National Jewish Health
Coordinator of this site? Confirm its status
DenverUnited StatesUnknown status
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
University of California at Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Columbia University
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Temple University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
University of California at San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Mayo Clinic - Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status
Wake Forest University
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.