Study of COPD Subgroups and Biomarkers (SPIROMICS)
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|ClinicalTrials.gov Identifier: NCT01969344|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : May 12, 2020
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|
|COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema|
|Study Type :||Observational|
|Actual Enrollment :||2981 participants|
|Official Title:||Subpopulations and Intermediate Outcome Measures in COPD Study|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||July 2022|
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).
Current and former smokers with at least a 20 pack-year history with severe COPD based on post-bronchodilator spirometry (n=625).
Current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry (n=1210).
Never-smokers with normal lung function on spirometry without use of bronchodilators (n=201).
- 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
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|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|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|