Study of COPD Subgroups and Biomarkers (SPIROMICS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01969344 |
Recruitment Status :
Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : January 13, 2023
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SPIROMICS I and SPIROMICS II are observational studies of Chronic Obstructive Pulmonary Disease (COPD).
SPIROMICS I had two main 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 so provide new ways of testing whether a new treatment is working.
SPIROMICS II has three primary aims. Aim 1 is to define the natural history of "Smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition. Aim 2 is to determine the radiographic precursor lesion(s) for emphysema, and identify the molecular phenotypes underlying airway disease and emphysema. Aim 3 is to advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.
Condition or disease |
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COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema |

Study Type : | Observational |
Actual Enrollment : | 2981 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Subpopulations and Intermediate Outcome Measures in COPD Study |
Study Start Date : | November 2010 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |

Group/Cohort |
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Smokers without COPD
Current or former smokers with at least a 20 pack-year history with normal lung function based on post-bronchodilator spirometry (n=944).
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Severe COPD
Current and former smokers with at least a 20 pack-year history with severe COPD based on post-bronchodilator spirometry (n=625).
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Mild/Moderate COPD
Current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry (n=1210).
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Non-smokers
Never-smokers with normal lung function on spirometry without use of bronchodilators (n=201).
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- Morbidity [ Time Frame: Up to end of follow-up (data presented up to month 36) ]Morbidity in SPIROMICS will primarily be measured by assessing acute exacerbations in the SPIROMICS cohort.
- Lung Function [ Time Frame: Up to end of follow-up (data presented up to month 36) ]COPD is characterized by physiological problems, such as airflow limitations and abnormalities of gas exchange and lung hyperinflation. These features of lung function are accessed objectively in the laboratory setting using spirometry/plethysmography, which can measure such parameters as FEV1 (forced expiratory volume in one second), FVC (forced vital capacity or total volume of air exhaled after full inspiration), FRC (functional residual capacity or volume of gas remaining in the lung at the end of tidal expiration), and IC (inspiratory capacity or maximum volume of gas that can be inspired from end-tidal expiration). The FDA preferred primary endpoint for assessment of alteration in disease progression in COPD is serial measurements of FEV1 over three years.
- Mortality [ Time Frame: Up to end of follow-up (data presented up to month 36) ]Deaths of SPIROMICS participants will be identified during follow-up calls and attempts to schedule clinic exams during the three-year study period, and deaths will be recorded in the clinical database. The cause of death will be determined via chart review and adjudication, and deaths attributable to COPD worsening or exacerbation will be recorded as confirmed clinical endpoints, in addition to contributing to the endpoint of all-cause mortality.
- Repeatability Substudy: Repeatability of clinic visit measurements [ Time Frame: Up to end of recruitment (2-6 week measurement repeatability) ]The repeatability of clinic visit measurements will be assessed at the end of this substudy. In this substudy all clinic procedures and samples are repeated/recollected 2-6 weeks after the baseline clinic visit in a subset of participants. This provides a measurement of short-term repeatability of these assessments.
- Exacerbation Substudy: Assess clinical and biological data in relation to an acute exacerbation [ Time Frame: Up to end of follow-up (data presented up to month 15) ]The exacerbation substudy will collect clinical and biological measurements during an acute exacerbation in a subset of participants. These will be used to better understand the biological processes underlying an acute exacerbation.
- Exacerbation Substudy: Assess symptomatic changes in COPD in relation to acute exacerbation [ Time Frame: Up to end of follow-up (data presented up to month 15) ]The exacerbation substudy will collect a daily symptom diary. Data from this daily diary will be used to characterize the stable versus exacerbative state in a subset of participants.
- Parametric Response Mapping in COPD: Structural assessment of the lung [ Time Frame: Up to end of follow-up (data presented up to month 36) ]In the PRM ancillary study, PRM metrics will be used to non-invasively evaluate the regional structural heterogeneity of the lung, including small airways disease and emphysema, and its relationship to clinical measurements.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969344
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35249 | |
United States, California | |
University of California at Los Angeles | |
Los Angeles, California, United States, 90095 | |
University of California at San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
National Jewish Health | |
Denver, Colorado, United States, 80206 | |
United States, Illinois | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Pennsylvania | |
Temple University | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | David Couper, PhD | University of North Carolina, Chapel Hill | |
Principal Investigator: | Graham Barr, PhD, MD | Columbia University | |
Principal Investigator: | Eugene Bleecker, MD | University of Arizona | |
Principal Investigator: | Robert Paine, MD | University of Utah | |
Principal Investigator: | Eric Hoffman, MD | University of Iowa | |
Study Chair: | Prescott Woodruff, MD | University of California at San Francisco | |
Principal Investigator: | Igor Barjaktarevic, MD | University of California at Los Angeles | |
Principal Investigator: | MeiLan Han, MD | University of Michigan | |
Principal Investigator: | Russell Bowler, MD | National Jewish Health | |
Principal Investigator: | Alejandro Cornellas, MD | University of Iowa | |
Principal Investigator: | Gerard Criner, MD | Temple University | |
Principal Investigator: | Mark Dransfield, MD | University of Alabama at Birmingham | |
Principal Investigator: | Nadia Hansel, MD | Johns Hopkins University | |
Principal Investigator: | Jerry Krishnan, MD | University of Illinois at Chicago | |
Principal Investigator: | Stephen Peters, MD | Wake Forest University |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01969344 |
Other Study ID Numbers: |
10-0048 HHSN268200900020C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN268200900013C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN268200900014C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN268200900015C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN268200900016C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN268200900017C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN268200900018C ( Other Identifier: National Heart, Lung, and Blood Institute ) HHSN2682009000019C ( Other Identifier: National Heart, Lung, and Blood Institute ) 5U01HL137880 ( U.S. NIH Grant/Contract ) 1U24HL141762 ( U.S. NIH Grant/Contract ) |
First Posted: | October 25, 2013 Key Record Dates |
Last Update Posted: | January 13, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | All data collected in SPIROMICS I have been submitted to the NHLBI data repository (BioLINCC). Updates will be submitted regularly during SPIROMICS II |
Supporting Materials: |
Study Protocol |
Time Frame: | Data from SPIROMICS I are currently available and will remain available indefinitely. |
Access Criteria: | Access criteria for data from BioLINCC are determined by NHLBI, not by the SPIROMICS Investigators. Criteria for obtaining data directly from SPIROMICS are provided on the web site given below. |
URL: | http://www2.cscc.unc.edu/spiromics/obtaining-data |
Bronchitis Bronchitis, Chronic Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Emphysema Lung Diseases |
Respiratory Tract Diseases Pathologic Processes Respiratory Tract Infections Infections Bronchial Diseases |