Study of COPD Subgroups and Biomarkers (SPIROMICS)
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.
Chronic Obstructive Pulmonary Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Subpopulations and Intermediate Markers in COPD Study|
- Morbidity [ Time Frame: Up to end of follow-up (data presented up to month 36) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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
Whole blood, serum, plasma, urine, lung biopsies, lung bronchial wash and lavage fluid, oral rinse and tongue scrapping, and sputum
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Smokers without COPD
Nine hundred current or former smokers with at least a 20 pack-year history with normal lung function based on post-bronchodilator spirometry.
Six hundred current and former smokers with at least a 20 pack-year history with sever COPD based on post-bronchodilator spirometry.
Fifteen hundred current and former smokers with at least a 20 pack-year history with mild to moderate COPD based on post-bronchodilator spirometry.
Two hundred never-smokers with normal lung function on spirometry without use of bronchodilators.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969344
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35249|
|Contact: Necole Harris 205-934-9240|
|Principal Investigator: Mark Dransfield, MD|
|United States, California|
|University of California at Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Marietta Wadley 310-825-3509|
|Principal Investigator: Eric Kleerup, MD|
|University of California at San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Chris Kirby 415-476-5125|
|Principal Investigator: Prescott Woodruff, MD|
|United States, Colorado|
|National Jewish Health||Recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Christina Schnell 303-398-1772|
|Principal Investigator: Russ Bowler, MD|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Rebecca Forney 410-550-2593|
|Principal Investigator: Nadia Hansel, MD|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Cheryl Majors 734-764-7388|
|Principal Investigator: Fernando Martinez, MD|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Casandra Almonte 212-342-4162|
|Principal Investigator: Graham Barr, PhD, MD|
|United States, North Carolina|
|Wake Forest University||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Penny Spernoga 336-713-8553|
|Principal Investigator: Eugene Bleecker, MD|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: Barbara Macdonald 215-707-9610|
|Principal Investigator: Gerald Criner, MD|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Martin Villegas 801-581-5864|
|Principal Investigator: Richard Kanner, MD|
|Principal Investigator:||David Couper, PhD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Graham Barr, PhD, MD||Columbia University|
|Principal Investigator:||Eugene Bleecker, MD||Wake Forest School of Medicine|
|Principal Investigator:||Fernando Martinez, MD||University of Michigan|
|Principal Investigator:||Richard Kanner, MD||University of Utah|
|Principal Investigator:||Eric Hoffman, MD||University of Iowa|
|Principal Investigator:||Prescott Woodruff, MD||University of California at San Francisco|
|Principal Investigator:||Eric Kleerup, MD||University of California at Los Angeles|
|Study Chair:||Steve Rennard, MD||University of Nebraska|