Study of COPD Subgroups and Biomarkers (SPIROMICS)

• ClinicalTrials.gov Identifier: NCT01969344
• Recruitment Status: Active, not recruiting
• First Posted: October 25, 2013
• Last Update Posted: May 12, 2020
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); COPD Foundation; Columbia University; Johns Hopkins University; National Jewish Health; Temple University; University of Alabama at Birmingham; University of California, Los Angeles; University of California, San Francisco; University of Illinois at Chicago; University of Iowa; University of Michigan; University of Utah; Wake Forest University
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief Summary:

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

Detailed Description:

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.

Substudies:

1. 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.
2. 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.
3. 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.

Ancillary Studies:

1. 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.
2. 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.

Study Design

• 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: May 2022
• Estimated Study Completion Date: July 2022

Groups and Cohorts

Group/Cohort
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).
Severe COPD; Current and former smokers with at least a 20 pack-year history with severe COPD based on post-bronchodilator spirometry (n=625).
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).
Non-smokers; Never-smokers with normal lung function on spirometry without use of bronchodilators (n=201).

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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

Whole blood, serum, plasma, urine, lung biopsies, lung bronchial wash and lavage fluid, oral rinse and tongue scrapping, and sputum

Eligibility Criteria

• 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

Study Population

Never-smokers, current and former smokers without COPD, and current and former smokers with COPD with access to one of the study clinical centers.

Criteria

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Heart, Lung, and Blood Institute (NHLBI)

COPD Foundation

Columbia University

Johns Hopkins University

National Jewish Health

Temple University

University of Alabama at Birmingham

University of California, Los Angeles

University of California, San Francisco

University of Illinois at Chicago

University of Iowa

University of Michigan

University of Utah

Wake Forest University

Investigators

• 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

More Information

Additional Information:

Study Website 

Publications of Results:

O'Neal WK, Anderson W, Basta PV, Carretta EE, Doerschuk CM, Barr RG, Bleecker ER, Christenson SA, Curtis JL, Han MK, Hansel NN, Kanner RE, Kleerup EC, Martinez FJ, Miller BE, Peters SP, Rennard SI, Scholand MB, Tal-Singer R, Woodruff PG, Couper DJ, Davis SM; SPIROMICS Investigators. Comparison of serum, EDTA plasma and P100 plasma for luminex-based biomarker multiplex assays in patients with chronic obstructive pulmonary disease in the SPIROMICS study. J Transl Med. 2014 Jan 8;12:9. doi: 10.1186/1479-5876-12-9.

Smith BM, Hoffman EA, Rabinowitz D, Bleecker E, Christenson S, Couper D, Donohue KM, Han MK, Hansel NN, Kanner RE, Kleerup E, Rennard S, Barr RG. Comparison of spatially matched airways reveals thinner airway walls in COPD. The Multi-Ethnic Study of Atherosclerosis (MESA) COPD Study and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 Nov;69(11):987-96. doi: 10.1136/thoraxjnl-2014-205160. Epub 2014 Jun 13.

Boes JL, Hoff BA, Bule M, Johnson TD, Rehemtulla A, Chamberlain R, Hoffman EA, Kazerooni EA, Martinez FJ, Han MK, Ross BD, Galbán CJ. Parametric response mapping monitors temporal changes on lung CT scans in the subpopulations and intermediate outcome measures in COPD Study (SPIROMICS). Acad Radiol. 2015 Feb;22(2):186-94. doi: 10.1016/j.acra.2014.08.015. Epub 2014 Nov 4.

Putcha N, Puhan MA, Drummond MB, Han MK, Regan EA, Hanania NA, Martinez CH, Foreman M, Bhatt SP, Make B, Ramsdell J, DeMeo DL, Barr RG, Rennard SI, Martinez F, Silverman EK, Crapo J, Wise RA, Hansel NN. A simplified score to quantify comorbidity in COPD. PLoS One. 2014 Dec 16;9(12):e114438. doi: 10.1371/journal.pone.0114438. eCollection 2014.

Paulin LM, Diette GB, Blanc PD, Putcha N, Eisner MD, Kanner RE, Belli AJ, Christenson S, Tashkin DP, Han M, Barr RG, Hansel NN; SPIROMICS Research Group. Occupational exposures are associated with worse morbidity in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015 Mar 1;191(5):557-65. doi: 10.1164/rccm.201408-1407OC.

Martinez CH, Diaz AA, Parulekar AD, Rennard SI, Kanner RE, Hansel NN, Couper D, Holm KE, Hoth KF, Curtis JL, Martinez FJ, Hanania NA, Regan EA, Paine R 3rd, Cigolle CT, Han MK; COPDGene and SPIROMICS Investigators. Age-Related Differences in Health-Related Quality of Life in COPD: An Analysis of the COPDGene and SPIROMICS Cohorts. Chest. 2016 Apr;149(4):927-35. doi: 10.1016/j.chest.2015.11.025. Epub 2015 Dec 17.

Putcha N, Barr RG, Han MK, Woodruff PG, Bleecker ER, Kanner RE, Martinez FJ, Smith BM, Tashkin DP, Bowler RP, Eisner MD, Rennard SI, Wise RA, Hansel NN; SPIROMICS Investigators. Understanding the impact of second-hand smoke exposure on clinical outcomes in participants with COPD in the SPIROMICS cohort. Thorax. 2016;71:411-420. doi: 10.1136/thoraxjnl-2015-207487. Epub 2016 Mar 9.

Guo J, Wang C, Chan KS, Jin D, Saha PK, Sieren JP, Barr RG, Han MK, Kazerooni E, Cooper CB, Couper D, Newell JD Jr, Hoffman EA; SPIROMICS Research Group. A controlled statistical study to assess measurement variability as a function of test object position and configuration for automated surveillance in a multicenter longitudinal COPD study (SPIROMICS). Med Phys. 2016 May;43(5):2598. doi: 10.1118/1.4947303.

Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.

Sun W, Kechris K, Jacobson S, Drummond MB, Hawkins GA, Yang J, Chen TH, Quibrera PM, Anderson W, Barr RG, Basta PV, Bleecker ER, Beaty T, Casaburi R, Castaldi P, Cho MH, Comellas A, Crapo JD, Criner G, Demeo D, Christenson SA, Couper DJ, Curtis JL, Doerschuk CM, Freeman CM, Gouskova NA, Han MK, Hanania NA, Hansel NN, Hersh CP, Hoffman EA, Kaner RJ, Kanner RE, Kleerup EC, Lutz S, Martinez FJ, Meyers DA, Peters SP, Regan EA, Rennard SI, Scholand MB, Silverman EK, Woodruff PG, O'Neal WK, Bowler RP; SPIROMICS Research Group; COPDGene Investigators. Common Genetic Polymorphisms Influence Blood Biomarker Measurements in COPD. PLoS Genet. 2016 Aug 17;12(8):e1006011. doi: 10.1371/journal.pgen.1006011. eCollection 2016 Aug.

Martinez CH, Diaz AA, Meldrum C, Curtis JL, Cooper CB, Pirozzi C, Kanner RE, Paine R 3rd, Woodruff PG, Bleecker ER, Hansel NN, Barr RG, Marchetti N, Criner GJ, Kazerooni EA, Hoffman EA, Ross BD, Galban CJ, Cigolle CT, Martinez FJ, Han MK; SPIROMICS Investigators. Age and Small Airway Imaging Abnormalities in Subjects with and without Airflow Obstruction in SPIROMICS. Am J Respir Crit Care Med. 2017 Feb 15;195(4):464-472. doi: 10.1164/rccm.201604-0871OC.

Keene JD, Jacobson S, Kechris K, Kinney GL, Foreman MG, Doerschuk CM, Make BJ, Curtis JL, Rennard SI, Barr RG, Bleecker ER, Kanner RE, Kleerup EC, Hansel NN, Woodruff PG, Han MK, Paine R 3rd, Martinez FJ, Bowler RP, O'Neal WK; COPDGene and SPIROMICS Investigators ‡. Biomarkers Predictive of Exacerbations in the SPIROMICS and COPDGene Cohorts. Am J Respir Crit Care Med. 2017 Feb 15;195(4):473-481. doi: 10.1164/rccm.201607-1330OC.

Hobbs BD, de Jong K, Lamontagne M, Bossé Y, Shrine N, Artigas MS, Wain LV, Hall IP, Jackson VE, Wyss AB, London SJ, North KE, Franceschini N, Strachan DP, Beaty TH, Hokanson JE, Crapo JD, Castaldi PJ, Chase RP, Bartz TM, Heckbert SR, Psaty BM, Gharib SA, Zanen P, Lammers JW, Oudkerk M, Groen HJ, Locantore N, Tal-Singer R, Rennard SI, Vestbo J, Timens W, Paré PD, Latourelle JC, Dupuis J, O'Connor GT, Wilk JB, Kim WJ, Lee MK, Oh YM, Vonk JM, de Koning HJ, Leng S, Belinsky SA, Tesfaigzi Y, Manichaikul A, Wang XQ, Rich SS, Barr RG, Sparrow D, Litonjua AA, Bakke P, Gulsvik A, Lahousse L, Brusselle GG, Stricker BH, Uitterlinden AG, Ampleford EJ, Bleecker ER, Woodruff PG, Meyers DA, Qiao D, Lomas DA, Yim JJ, Kim DK, Hawrylkiewicz I, Sliwinski P, Hardin M, Fingerlin TE, Schwartz DA, Postma DS, MacNee W, Tobin MD, Silverman EK, Boezen HM, Cho MH; COPDGene Investigators; ECLIPSE Investigators; LifeLines Investigators; SPIROMICS Research Group; International COPD Genetics Network Investigators; UK BiLEVE Investigators; International COPD Genetics Consortium. Genetic loci associated with chronic obstructive pulmonary disease overlap with loci for lung function and pulmonary fibrosis. Nat Genet. 2017 Mar;49(3):426-432. doi: 10.1038/ng.3752. Epub 2017 Feb 6.

Han MK, Quibrera PM, Carretta EE, Barr RG, Bleecker ER, Bowler RP, Cooper CB, Comellas A, Couper DJ, Curtis JL, Criner G, Dransfield MT, Hansel NN, Hoffman EA, Kanner RE, Krishnan JA, Martinez CH, Pirozzi CB, O'Neal WK, Rennard S, Tashkin DP, Wedzicha JA, Woodruff P, Paine R 3rd, Martinez FJ; SPIROMICS investigators. Frequency of exacerbations in patients with chronic obstructive pulmonary disease: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2017 Aug;5(8):619-626. doi: 10.1016/S2213-2600(17)30207-2. Epub 2017 Jun 28.

Kesimer M, Ford AA, Ceppe A, Radicioni G, Cao R, Davis CW, Doerschuk CM, Alexis NE, Anderson WH, Henderson AG, Barr RG, Bleecker ER, Christenson SA, Cooper CB, Han MK, Hansel NN, Hastie AT, Hoffman EA, Kanner RE, Martinez F, Paine R 3rd, Woodruff PG, O'Neal WK, Boucher RC. Airway Mucin Concentration as a Marker of Chronic Bronchitis. N Engl J Med. 2017 Sep 7;377(10):911-922. doi: 10.1056/NEJMoa1701632.

Bowler RP, Hansel NN, Jacobson S, Graham Barr R, Make BJ, Han MK, O'Neal WK, Oelsner EC, Casaburi R, Barjaktarevic I, Cooper C, Foreman M, Wise RA, DeMeo DL, Silverman EK, Bailey W, Harrington KF, Woodruff PG, Drummond MB; for COPDGene and SPIROMICS Investigators. Electronic Cigarette Use in US Adults at Risk for or with COPD: Analysis from Two Observational Cohorts. J Gen Intern Med. 2017 Dec;32(12):1315-1322. doi: 10.1007/s11606-017-4150-7. Epub 2017 Sep 7.

Martinez CH, Li SX, Hirzel AJ, Stolberg VR, Alexis NE, Barr RG, Bleecker ER, Carretta EE, Christenson SA, Cooper CB, Couper DJ, Doerschuk CM, Han MK, Hansel NN, Hastie AT, Hoffman EA, Kaner RJ, Martinez FJ, Meyers DA, O'Neal WK, Paine R 3rd, Putcha N, Rennard SI, Woodruff PG, Zeidler M, Curtis JL, Freeman CM; SPIROMICS Investigators. Alveolar eosinophilia in current smokers with chronic obstructive pulmonary disease in the SPIROMICS cohort. J Allergy Clin Immunol. 2018 Jan;141(1):429-432. doi: 10.1016/j.jaci.2017.07.039. Epub 2017 Sep 12.

Anderson WH, Ha JW, Couper DJ, O'Neal WK, Barr RG, Bleecker ER, Carretta EE, Cooper CB, Doerschuk CM, Drummond MB, Han MK, Hansel NN, Kim V, Kleerup EC, Martinez FJ, Rennard SI, Tashkin D, Woodruff PG, Paine R 3rd, Curtis JL, Kanner RE; SPIROMICS Research Group. Variability in objective and subjective measures affects baseline values in studies of patients with COPD. PLoS One. 2017 Sep 21;12(9):e0184606. doi: 10.1371/journal.pone.0184606. eCollection 2017.

Bradford E, Jacobson S, Varasteh J, Comellas AP, Woodruff P, O'Neal W, DeMeo DL, Li X, Kim V, Cho M, Castaldi PJ, Hersh C, Silverman EK, Crapo JD, Kechris K, Bowler RP. The value of blood cytokines and chemokines in assessing COPD. Respir Res. 2017 Oct 24;18(1):180. doi: 10.1186/s12931-017-0662-2.

Hastie AT, Martinez FJ, Curtis JL, Doerschuk CM, Hansel NN, Christenson S, Putcha N, Ortega VE, Li X, Barr RG, Carretta EE, Couper DJ, Cooper CB, Hoffman EA, Kanner RE, Kleerup E, O'Neal WK, Paine R 3rd, Peters SP, Alexis NE, Woodruff PG, Han MK, Meyers DA, Bleecker ER; SPIROMICS investigators. Association of sputum and blood eosinophil concentrations with clinical measures of COPD severity: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2017 Dec;5(12):956-967. doi: 10.1016/S2213-2600(17)30432-0. Epub 2017 Nov 13.

Smith BM, Traboulsi H, Austin JHM, Manichaikul A, Hoffman EA, Bleecker ER, Cardoso WV, Cooper C, Couper DJ, Dashnaw SM, Guo J, Han MK, Hansel NN, Hughes EW, Jacobs DR Jr, Kanner RE, Kaufman JD, Kleerup E, Lin CL, Liu K, Lo Cascio CM, Martinez FJ, Nguyen JN, Prince MR, Rennard S, Rich SS, Simon L, Sun Y, Watson KE, Woodruff PG, Baglole CJ, Barr RG; MESA Lung and SPIROMICS investigators. Human airway branch variation and chronic obstructive pulmonary disease. Proc Natl Acad Sci U S A. 2018 Jan 30;115(5):E974-E981. doi: 10.1073/pnas.1715564115. Epub 2018 Jan 16.

Fawzy A, Putcha N, Paulin LM, Aaron CP, Labaki WW, Han MK, Wise RA, Kanner RE, Bowler RP, Barr RG, Hansel NN; SPIROMICS and COPDGene Investigators. Association of thrombocytosis with COPD morbidity: the SPIROMICS and COPDGene cohorts. Respir Res. 2018 Jan 26;19(1):20. doi: 10.1186/s12931-018-0717-z.

Fernández-Baldera A, Hatt CR, Murray S, Hoffman EA, Kazerooni EA, Martinez FJ, Han MK, Galbán CJ. Correcting Nonpathological Variation in Longitudinal Parametric Response Maps of CT Scans in COPD Subjects: SPIROMICS. Tomography. 2017 Sep;3(3):138-145. doi: 10.18383/j.tom.2017.00013.

Han MK, Tayob N, Murray S, Woodruff PG, Curtis JL, Kim V, Criner G, Galban CJ, Ross BD, Hoffman EA, Lynch DA, Kazerooni E, Martinez FJ; COPDGene and SPIROMICS Investigators. Association between Emphysema and Chronic Obstructive Pulmonary Disease Outcomes in the COPDGene and SPIROMICS Cohorts: A Post Hoc Analysis of Two Clinical Trials. Am J Respir Crit Care Med. 2018 Jul 15;198(2):265-267. doi: 10.1164/rccm.201801-0051LE.

Zeidler MR, Martin JL, Kleerup EC, Schneider H, Mitchell MN, Hansel NN, Sundar K, Schotland H, Basner RC, Wells JM, Krishnan JA, Criner GJ, Cristenson S, Krachman S, Badr MS; SPIROMICS Research Group. Sleep disruption as a predictor of quality of life among patients in the subpopulations and intermediate outcome measures in COPD study (SPIROMICS). Sleep. 2018 May 1;41(5). doi: 10.1093/sleep/zsy044.

Burkes RM, Gassett AJ, Ceppe AS, Anderson W, O'Neal WK, Woodruff PG, Krishnan JA, Barr RG, Han MK, Martinez FJ, Comellas AP, Lambert AA, Kaufman JD, Dransfield MT, Wells JM, Kanner RE, Paine R 3rd, Bleecker ER, Paulin LM, Hansel NN, Drummond MB; Current and former investigators of the SPIROMICS sites and reading centers. Rural Residence and Chronic Obstructive Pulmonary Disease Exacerbations. Analysis of the SPIROMICS Cohort. Ann Am Thorac Soc. 2018 Jul;15(7):808-816. doi: 10.1513/AnnalsATS.201710-837OC.

Morris MA, Jacobson SR, Kinney GL, Tashkin DP, Woodruff PG, Hoffman EA, Kanner RE, Cooper CB, Drummond MB, Barr RG, Oelsner EC, Make BJ, Han MK, Hansel NN, O'Neal WK, Bowler RP. Marijuana Use Associations with Pulmonary Symptoms and Function in Tobacco Smokers Enrolled in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). Chronic Obstr Pulm Dis. 2018 Jan 24;5(1):46-56. doi: 10.15326/jcopdf.5.1.2017.0141.

Putcha N, Paul GG, Azar A, Wise RA, O'Neal WK, Dransfield MT, Woodruff PG, Curtis JL, Comellas AP, Drummond MB, Lambert AA, Paulin LM, Fawzy A, Kanner RE, Paine R 3rd, Han MK, Martinez FJ, Bowler RP, Barr RG, Hansel NN; SPIROMICS investigators. Lower serum IgA is associated with COPD exacerbation risk in SPIROMICS. PLoS One. 2018 Apr 12;13(4):e0194924. doi: 10.1371/journal.pone.0194924. eCollection 2018.

Labaki WW, Xia M, Murray S, Curtis JL, Barr RG, Bhatt SP, Bleecker ER, Hansel NN, Cooper CB, Dransfield MT, Wells JM, Hoffman EA, Kanner RE, Paine R 3rd, Ortega VE, Peters SP, Krishnan JA, Bowler RP, Couper DJ, Woodruff PG, Martinez FJ, Martinez CH, Han MK. NT-proBNP in stable COPD and future exacerbation risk: Analysis of the SPIROMICS cohort. Respir Med. 2018 Jul;140:87-93. doi: 10.1016/j.rmed.2018.06.005. Epub 2018 Jun 5.

Li X, Ortega VE, Ampleford EJ, Graham Barr R, Christenson SA, Cooper CB, Couper D, Dransfield MT, Han MLK, Hansel NN, Hoffman EA, Kanner RE, Kleerup EC, Martinez FJ, Paine R 3rd, Woodruff PG, Hawkins GA, Bleecker ER, Meyers DA; SPIROMICS Research Group. Genome-wide association study of lung function and clinical implication in heavy smokers. BMC Med Genet. 2018 Aug 1;19(1):134. doi: 10.1186/s12881-018-0656-z.

Kesimer M, Smith BM, Ceppe A, Ford AA, Anderson WH, Barr RG, O'Neal WK, Boucher RC; SPIROMICS Investigative Group. Mucin Concentrations and Peripheral Airway Obstruction in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Dec 1;198(11):1453-1456. doi: 10.1164/rccm.201806-1016LE.

Ghosh S, Anderson WH, Putcha N, Han MK, Curtis JL, Criner GJ, Dransfield MT, Barr RG, Krishnan JA, Lazarus SC, Cooper CB, Paine R 3rd, Peters SP, Hansel NN, Martinez FJ, Drummond MB; Current and former investigators of the SPIROMICS sites and reading centers. Alignment of Inhaled Chronic Obstructive Pulmonary Disease Therapies with Published Strategies. Analysis of the Global Initiative for Chronic Obstructive Lung Disease Recommendations in SPIROMICS. Ann Am Thorac Soc. 2019 Feb;16(2):200-208. doi: 10.1513/AnnalsATS.201804-283OC.

Haghighi B, Choi S, Choi J, Hoffman EA, Comellas AP, Newell JD Jr, Graham Barr R, Bleecker E, Cooper CB, Couper D, Han ML, Hansel NN, Kanner RE, Kazerooni EA, Kleerup EAC, Martinez FJ, O'Neal W, Rennard SI, Woodruff PG, Lin CL. Imaging-based clusters in current smokers of the COPD cohort associate with clinical characteristics: the SubPopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). Respir Res. 2018 Sep 18;19(1):178. doi: 10.1186/s12931-018-0888-7.

Paulin LM, Smith BM, Koch A, Han M, Hoffman EA, Martinez C, Ejike C, Blanc PD, Rous J, Barr RG, Peters SP, Paine R 3rd, Pirozzi C, Cooper CB, Dransfield MT, Comellas AP, Kanner RE, Drummond MB, Putcha N, Hansel NN. Occupational Exposures and Computed Tomographic Imaging Characteristics in the SPIROMICS Cohort. Ann Am Thorac Soc. 2018 Dec;15(12):1411-1419. doi: 10.1513/AnnalsATS.201802-150OC.

Christenson SA, van den Berge M, Faiz A, Inkamp K, Bhakta N, Bonser LR, Zlock LT, Barjaktarevic IZ, Barr RG, Bleecker ER, Boucher RC, Bowler RP, Comellas AP, Curtis JL, Han MK, Hansel NN, Hiemstra PS, Kaner RJ, Krishnanm JA, Martinez FJ, O'Neal WK, Paine R 3rd, Timens W, Wells JM, Spira A, Erle DJ, Woodruff PG. An airway epithelial IL-17A response signature identifies a steroid-unresponsive COPD patient subgroup. J Clin Invest. 2019 Jan 2;129(1):169-181. doi: 10.1172/JCI121087. Epub 2018 Nov 26.

Wells JM, Parker MM, Oster RA, Bowler RP, Dransfield MT, Bhatt SP, Cho MH, Kim V, Curtis JL, Martinez FJ, Paine R 3rd, O'Neal W, Labaki WW, Kaner RJ, Barjaktarevic I, Han MK, Silverman EK, Crapo JD, Barr RG, Woodruff P, Castaldi PJ, Gaggar A; SPIROMICS and COPDGene Investigators. Elevated circulating MMP-9 is linked to increased COPD exacerbation risk in SPIROMICS and COPDGene. JCI Insight. 2018 Nov 15;3(22). pii: 123614. doi: 10.1172/jci.insight.123614.

Pirozzi CS, Gu T, Quibrera PM, Carretta EE, Han MK, Murray S, Cooper CB, Tashkin DP, Kleerup EC, Barjaktarevic I, Hoffman EA, Martinez CH, Christenson SA, Hansel NN, Graham Barr R, Bleecker ER, Ortega VE, Martinez FJ, Kanner RE, Paine R 3rd; NHLBI SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS). Heterogeneous burden of lung disease in smokers with borderline airflow obstruction. Respir Res. 2018 Nov 20;19(1):223. doi: 10.1186/s12931-018-0911-z.

Bhatt SP, Nath HP, Kim YI, Ramachandran R, Watts JR, Terry NLJ, Sonavane S, Deshmane SP, Woodruff PG, Oelsner EC, Bodduluri S, Han MK, Labaki WW, Michael Wells J, Martinez FJ, Barr RG, Dransfield MT; SPIROMICS investigators. Centrilobular emphysema and coronary artery calcification: mediation analysis in the SPIROMICS cohort. Respir Res. 2018 Dec 18;19(1):257. doi: 10.1186/s12931-018-0946-1.

Fawzy A, Putcha N, Aaron CP, Bowler RP, Comellas AP, Cooper CB, Dransfield MT, Han MK, Hoffman EA, Kanner RE, Krishnan JA, Labaki WW, Paine R 3rd, Paulin LM, Peters SP, Wise R, Barr RG, Hansel NN; SPIROMICS Investigators. Aspirin Use and Respiratory Morbidity in COPD: A Propensity Score-Matched Analysis in Subpopulations and Intermediate Outcome Measures in COPD Study. Chest. 2019 Mar;155(3):519-527. doi: 10.1016/j.chest.2018.11.028. Epub 2018 Dec 26.

Wells JM, Arenberg DA, Barjaktarevic I, Bhatt SP, Bowler RP, Christenson SA, Couper DJ, Dransfield MT, Han MK, Hoffman EA, Kaner RJ, Kim V, Kleerup E, Martinez FJ, Moore WC, O'Beirne SL, Paine R 3rd, Putcha N, Raman SM, Barr RG, Rennard SI, Woodruff PG, Curtis JL. Safety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy. Ann Am Thorac Soc. 2019 Apr;16(4):439-446. doi: 10.1513/AnnalsATS.201807-441OC.

Garudadri S, Woodruff PG, Han MK, Curtis JL, Barr RG, Bleecker ER, Bowler RP, Comellas A, Cooper CB, Criner G, Dransfield MT, Hansel NN, Paine R 3rd, Krishnan JA, Peters SP, Hastie AT, Martinez FJ, O'Neal WK, Couper DJ, Alexis NE, Christenson SA. Systemic Markers of Inflammation in Smokers With Symptoms Despite Preserved Spirometry in SPIROMICS. Chest. 2019 May;155(5):908-917. doi: 10.1016/j.chest.2018.12.022. Epub 2019 Jan 23.

Putcha N, Fawzy A, Paul GG, Lambert AA, Psoter KJ, Sidhaye VK, Woo J, Wells JM, Labaki WW, Doerschuk CM, Kanner RE, Han MK, Martinez C, Paulin LM, Martinez FJ, Wise RA, O'Neal WK, Barr RG, Hansel NN; SPIROMICS investigators. Anemia and Adverse Outcomes in a Chronic Obstructive Pulmonary Disease Population with a High Burden of Comorbidities. An Analysis from SPIROMICS. Ann Am Thorac Soc. 2018 Jun;15(6):710-717. doi: 10.1513/AnnalsATS.201708-687OC.

Oelsner EC, Ortega VE, Smith BM, Nguyen JN, Manichaikul AW, Hoffman EA, Guo X, Taylor KD, Woodruff PG, Couper DJ, Hansel NN, Martinez FJ, Paine R 3rd, Han MK, Cooper C, Dransfield MT, Criner G, Krishnan JA, Bowler R, Bleecker ER, Peters S, Rich SS, Meyers DA, Rotter JI, Barr RG. A Genetic Risk Score Associated with Chronic Obstructive Pulmonary Disease Susceptibility and Lung Structure on Computed Tomography. Am J Respir Crit Care Med. 2019 Sep 15;200(6):721-731. doi: 10.1164/rccm.201812-2355OC.

Cho HB, Chae KJ, Jin GY, Choi J, Lin CL, Hoffman EA, Wenzel SE, Castro M, Fain SB, Jarjour NN, Schiebler ML, Barr RG, Hansel N, Cooper CB, Kleerup EC, Han MK, Woodruff PG, Kanner RE, Bleecker ER, Peters SP, Moore WC, Lee CH, Choi S; National Heart, Lung and Blood Institute's SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) and Severe Asthma Research Program (SARP). Structural and Functional Features on Quantitative Chest Computed Tomography in the Korean Asian versus the White American Healthy Non-Smokers. Korean J Radiol. 2019 Jul;20(7):1236-1245. doi: 10.3348/kjr.2019.0083. Erratum in: Korean J Radiol. 2020 Jan;21(1):117.

Haghighi B, Choi S, Choi J, Hoffman EA, Comellas AP, Newell JD Jr, Lee CH, Barr RG, Bleecker E, Cooper CB, Couper D, Han ML, Hansel NN, Kanner RE, Kazerooni EA, Kleerup EAC, Martinez FJ, O'Neal W, Paine R 3rd, Rennard SI, Smith BM, Woodruff PG, Lin CL. Imaging-based clusters in former smokers of the COPD cohort associate with clinical characteristics: the SubPopulations and intermediate outcome measures in COPD study (SPIROMICS). Respir Res. 2019 Jul 15;20(1):153. doi: 10.1186/s12931-019-1121-z.

Halper-Stromberg E, Gillenwater L, Cruickshank-Quinn C, O'Neal WK, Reisdorph N, Petrache I, Zhuang Y, Labaki WW, Curtis JL, Wells J, Rennard S, Pratte KA, Woodruff P, Stringer KA, Kechris K, Bowler RP. Bronchoalveolar Lavage Fluid from COPD Patients Reveals More Compounds Associated with Disease than Matched Plasma. Metabolites. 2019 Jul 25;9(8). pii: E157. doi: 10.3390/metabo9080157.

Labaki WW, Gu T, Murray S, Curtis JL, Yeomans L, Bowler RP, Barr RG, Comellas AP, Hansel NN, Cooper CB, Barjaktarevic I, Kanner RE, Paine R 3rd, McDonald MN, Krishnan JA, Peters SP, Woodruff PG, O'Neal WK, Diao W, He B, Martinez FJ, Standiford TJ, Stringer KA, Han MK. Serum amino acid concentrations and clinical outcomes in smokers: SPIROMICS metabolomics study. Sci Rep. 2019 Aug 6;9(1):11367. doi: 10.1038/s41598-019-47761-w.

Arjomandi M, Zeng S, Barjaktarevic I, Barr RG, Bleecker ER, Bowler RP, Buhr RG, Criner GJ, Comellas AP, Cooper CB, Couper DJ, Curtis JL, Dransfield MT, Han MK, Hansel NN, Hoffman EA, Kaner RJ, Kanner RE, Krishnan JA, Paine R 3rd, Peters SP, Rennard SI, Woodruff PG; SPIROMICS Investigators. Radiographic lung volumes predict progression to COPD in smokers with preserved spirometry in SPIROMICS. Eur Respir J. 2019 Oct 31;54(4). pii: 1802214. doi: 10.1183/13993003.02214-2018. Print 2019 Oct.

Ortega VE, Li X, O'Neal WK, Lackey L, Ampleford E, Hawkins GA, Grayeski PJ, Laederach A, Barjaktarevic I, Barr RG, Cooper C, Couper D, Han MK, Kanner RE, Kleerup EC, Martinez FJ, Paine R 3rd, Peters SP, Pirozzi C, Rennard SI, Woodruff PG, Hoffman EA, Meyers DA, Bleecker ER; NHLBI Subpopulations and Intermediate Outcomes Measures in COPD Study (SPIROMICS). The Effects of Rare SERPINA1 Variants on Lung Function and Emphysema in SPIROMICS. Am J Respir Crit Care Med. 2020 Mar 1;201(5):540-554. doi: 10.1164/rccm.201904-0769OC.

Wells JM, Xing D, Viera L, Burkes RM, Wu Y, Bhatt SP, Dransfield MT, Couper DJ, O'Neal W, Hoffman EA, Gaggar A, Barjaktarevic I, Curtis JL, Labaki WW, Han MLK, Freeman CM, Putcha N, Schlange T, Blalock JE; SPIROMICS Investigators,. The matrikine acetyl-proline-glycine-proline and clinical features of COPD: findings from SPIROMICS. Respir Res. 2019 Nov 12;20(1):254. doi: 10.1186/s12931-019-1230-8.

Paulin LM, Gassett AJ, Alexis NE, Kirwa K, Kanner RE, Peters S, Krishnan JA, Paine R 3rd, Dransfield M, Woodruff PG, Cooper CB, Barr RG, Comellas AP, Pirozzi CS, Han M, Hoffman EA, Martinez FJ, Woo H, Peng RD, Fawzy A, Putcha N, Breysse PN, Kaufman JD, Hansel NN; for SPIROMICS investigators. Association of Long-term Ambient Ozone Exposure With Respiratory Morbidity in Smokers. JAMA Intern Med. 2019 Dec 9. doi: 10.1001/jamainternmed.2019.5498. [Epub ahead of print]

Zhang WZ, Rice MC, Hoffman KL, Oromendia C, Barjaktarevic IZ, Wells JM, Hastie AT, Labaki WW, Cooper CB, Comellas AP, Criner GJ, Krishnan JA, Paine R 3rd, Hansel NN, Bowler RP, Barr RG, Peters SP, Woodruff PG, Curtis JL, Han MK, Ballman KV, Martinez FJ, Choi AM, Nakahira K, Cloonan SM, Choi ME; SPIROMICS Investigators. Association of urine mitochondrial DNA with clinical measures of COPD in the SPIROMICS cohort. JCI Insight. 2020 Feb 13;5(3). pii: 133984. doi: 10.1172/jci.insight.133984.

Barjaktarevic IZ, Buhr RG, Wang X, Hu S, Couper D, Anderson W, Kanner RE, Paine Iii R, Bhatt SP, Bhakta NR, Arjomandi M, Kaner RJ, Pirozzi CS, Curtis JL, O'Neal WK, Woodruff PG, Han MK, Martinez FJ, Hansel N, Wells JM, Ortega VE, Hoffman EA, Doerschuk CM, Kim V, Dransfield MT, Drummond MB, Bowler R, Criner G, Christenson SA, Ronish B, Peters SP, Krishnan JA, Tashkin DP, Cooper CB; NHLBI SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS). Clinical Significance of Bronchodilator Responsiveness Evaluated by Forced Vital Capacity in COPD: SPIROMICS Cohort Analysis. Int J Chron Obstruct Pulmon Dis. 2019 Dec 20;14:2927-2938. doi: 10.2147/COPD.S220164. eCollection 2019. Erratum in: Int J Chron Obstruct Pulmon Dis. 2020 Apr 23;15:901.

Burkes RM, Ceppe AS, Doerschuk CM, Couper D, Hoffman EA, Comellas AP, Barr RG, Krishnan JA, Cooper C, Labaki WW, Ortega VE, Wells JM, Criner GJ, Woodruff PG, Bowler RP, Pirozzi CS, Hansel NN, Wise RA, Brown TT, Drummond MB; SPIROMICS Investigators. Associations Among 25-Hydroxyvitamin D Levels, Lung Function, and Exacerbation Outcomes in COPD: An Analysis of the SPIROMICS Cohort. Chest. 2020 Apr;157(4):856-865. doi: 10.1016/j.chest.2019.11.047. Epub 2020 Jan 17.

Other Publications:

Couper D, LaVange LM, Han M, Barr RG, Bleecker E, Hoffman EA, Kanner R, Kleerup E, Martinez FJ, Woodruff PG, Rennard S; SPIROMICS Research Group. Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 May;69(5):491-4. doi: 10.1136/thoraxjnl-2013-203897. Epub 2013 Sep 12.

Freeman CM, Crudgington S, Stolberg VR, Brown JP, Sonstein J, Alexis NE, Doerschuk CM, Basta PV, Carretta EE, Couper DJ, Hastie AT, Kaner RJ, O'Neal WK, Paine R 3rd, Rennard SI, Shimbo D, Woodruff PG, Zeidler M, Curtis JL. Design of a multi-center immunophenotyping analysis of peripheral blood, sputum and bronchoalveolar lavage fluid in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). J Transl Med. 2015 Jan 27;13:19. doi: 10.1186/s12967-014-0374-z.

Sieren JP, Newell JD Jr, Barr RG, Bleecker ER, Burnette N, Carretta EE, Couper D, Goldin J, Guo J, Han MK, Hansel NN, Kanner RE, Kazerooni EA, Martinez FJ, Rennard S, Woodruff PG, Hoffman EA; SPIROMICS Research Group. SPIROMICS Protocol for Multicenter Quantitative Computed Tomography to Phenotype the Lungs. Am J Respir Crit Care Med. 2016 Oct 1;194(7):794-806.

Hansel NN, Paulin LM, Gassett AJ, Peng RD, Alexis N, Fan VS, Bleecker E, Bowler R, Comellas AP, Dransfield M, Han MK, Kim V, Krishnan JA, Pirozzi C, Cooper CB, Martinez F, Woodruff PG, Breysse PJ, Barr RG, Kaufman JD. Design of the Subpopulations and Intermediate Outcome Measures in COPD (SPIROMICS) AIR Study. BMJ Open Respir Res. 2017 May 18;4(1):e000186. doi: 10.1136/bmjresp-2017-000186. eCollection 2017.

• 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
• Last Update Posted: May 12, 2020
• Last Verified: May 2020

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

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic; Emphysema; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Bronchial Diseases; Respiratory Tract Infections