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 : February 2, 2018
SPIROMICS was initially funded through contracts from the NIH. That phase of SPIROMICS is now referred to as SPIROMICS I. SPIROMICS is now funded as a grant from the NIH. The current phase is referred to as SPIROMICS II.
Brief summary of SPIROMICS I:
The purpose of SPIROMICS is to learn about chronic obstructive pulmonary disease (COPD), which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD, and it is the fourth leading cause of death in the country. The most common cause of COPD is cigarette smoking, although not all smokers get COPD. The discovery of new treatments for COPD has been slowed by a poor understanding of different types of COPD and a lack of ways to measure whether or not COPD is getting worse.
The study has two main goals. The first is to find groups of patients with COPD who share certain characteristics. Certain groups may respond differently to certain treatments. The second is to find new ways of measuring whether or not COPD is getting worse. This would provide new ways of testing whether a new treatment is working.
SPIROMICS has three substudies and two ancillary studies.
- Repeatability Substudy: The entire baseline clinic visit will be repeated on 100 volunteers. The goal of this substudy is to determine reliability of measurement procedures.
- Bronchoscopy Substudy: 300 participants will be enrolled for two additional study visits, including a bronchoscopy. The goal of this substudy is to collect and assess biological specimens and relate those results to clinical measurements.
- Exacerbation Substudy: Up to 400 participants will be enrolled in this substudy. A daily symptom diary will be collected on all participants. Participants will also be seen in the clinic during a pulmonary exacerbation. The goals of this substudy are to 1) better understand the relationship between symptoms and exacerbations and 2) obtain clinical data and specimens during a pulmonary exacerbation.
- Air Pollution Ancillary Study: The SPIROMICS Air Pollution ancillary study uses state-of-the art air pollution exposure assessments to determine individual-level outdoor and indoor air pollution exposure. The goals of this substudy are to determine the effect of long-term air pollution exposure on COPD morbidity and to determine whether short-term changes in outdoor air pollution are associated with changes in COPD morbidity.
- Parametric Response Mapping in COPD: The Parametric Response Mapping (PRM) in COPD ancillary study collects an additional CT scan during the final study visit and uses a new analysis technique (PRM) to assess the functional small airways of the lung and emphysema.
Brief summary of SPIROMICS II:
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.
SPIROMICS II will continue follow-up of current participants, with no new enrollment. Each participant will have one clinic visit and will be contacted by telephone every 4 months.
|Condition or disease|
|COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema|
|Study Type :||Observational|
|Actual Enrollment :||2981 participants|
|Official Title:||Subpopulations and Intermediate Markers in COPD Study|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 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 SPRIOMICS 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
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:||Christopher Cooper, 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|