Study of COPD Subgroups and Biomarkers

Chronic Obstructive Pulmonary Disease Clinical Trial

— SPIROMICS  

Official title:

Subpopulations and Intermediate Outcome Measures in COPD Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01969344
• Other study ID #: 10-0048
• Secondary ID: HHSN268200900020
• Status: Active, not recruiting
• Start date: November 2010
• Est. completion date: July 2024

Study information

• Verified date: January 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2981
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• COPD
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Illinois at Chicago	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	University of Iowa	Iowa City	Iowa
United States	University of California at Los Angeles	Los Angeles	California
United States	Columbia University	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	University of California at San Francisco	San Francisco	California
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (15)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Columbia University, COPD Foundation, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), 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

Country where clinical trial is conducted

United States, 

References & Publications (114)

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 — View Citation

Angelini ED, Yang J, Balte PP, Hoffman EA, Manichaikul AW, Sun Y, Shen W, Austin JHM, Allen NB, Bleecker ER, Bowler R, Cho MH, Cooper CS, Couper D, Dransfield MT, Garcia CK, Han MK, Hansel NN, Hughes E, Jacobs DR, Kasela S, Kaufman JD, Kim JS, Lappalainen — View Citation

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, Wo — View Citation

Arjomandi M, Zeng S, Chen J, Bhatt SP, Abtin F, Barjaktarevic I, Barr RG, Bleecker ER, Buhr RG, Criner GJ, Comellas AP, Couper DJ, Curtis JL, Dransfield MT, Fortis S, Han MK, Hansel NN, Hoffman EA, Hokanson JE, Kaner RJ, Kanner RE, Krishnan JA, Labaki WW, — View Citation

Barjaktarevic I, Cooper CB, Shing T, Buhr RG, Hoffman EA, Woodruff PG, Drummond MB, Kanner RE, Han MK, Hansel NN, Bowler RP, Kinney GL, Jacobson S, Morris MA, Martinez FJ, Ohar J, Couper D, Tashkin DP. Impact of Marijuana Smoking on COPD Progression in a — View Citation

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, — View Citation

Baugh A, Buhr RG, Quibrera P, Barjaktarevic I, Barr RG, Bowler R, Han MK, Kaufman JD, Koch AL, Krishnan J, Labaki W, Martinez FJ, Mkorombindo T, Namen A, Ortega V, Paine R, Peters SP, Schotland H, Sundar K, Zeidler MR, Hansel NN, Woodruff PG, Thakur N. Ri — View Citation

Baugh AD, Acho M, Arhin A, Barjaktarevic I, Couper D, Criner G, Han M, Hansel N, Krishnan J, Malcolm K, Namen A, Peters S, Schotland H, Sowho M, Zeidler M, Woodruff P, Thakur N. African American race is associated with worse sleep quality in heavy smokers — View Citation

Belz DC, Woo H, Putcha N, Paulin LM, Koehler K, Fawzy A, Alexis NE, Barr RG, Comellas AP, Cooper CB, Couper D, Dransfield M, Gassett AJ, Han M, Hoffman EA, Kanner RE, Krishnan JA, Martinez FJ, Paine R 3rd, Peng RD, Peters S, Pirozzi CS, Woodruff PG, Kaufm — View Citation

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 co — View Citation

Boes JL, Hoff BA, Bule M, Johnson TD, Rehemtulla A, Chamberlain R, Hoffman EA, Kazerooni EA, Martinez FJ, Han MK, Ross BD, Galban CJ. Parametric response mapping monitors temporal changes on lung CT scans in the subpopulations and intermediate outcome mea — View Citation

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 Inves — View Citation

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 — View Citation

Buhr RG, Barjaktarevic IZ, Quibrera PM, Bateman LA, Bleecker ER, Couper DJ, Curtis JL, Dolezal BA, Han MK, Hansel NN, Krishnan JA, Martinez FJ, McKleroy W, Paine R 3rd, Rennard SI, Tashkin DP, Woodruff PG, Kanner RE, Cooper CB; SPIROMICS Investigators. Re — View Citation

Burkes RM, Ceppe AS, Couper DJ, Comellas AP, Wells JM, Peters SP, Criner GJ, Kanner RE, Paine R 3rd, Christenson SA, Cooper CB, Barjaktarevic IZ, Krishnan JA, Labaki WW, Han MK, Curtis JL, Hansel NN, Wise RA, Drummond MB; SPIROMICS collaborators. Plasma C — View Citation

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. Associ — View Citation

Burkes RM, Couper DJ, Barjaktarevic IZ, Cooper CB, Labaki WW, Han MK, Woodruff PG, Lazarus SC, Parekh TM, Paine R 3rd, Comellas AP, Bowler RP, Loehr LR, Putcha N, Wise RA, Brown TT, Drummond MB. Age-Dependent Associations Between 25-Hydroxy Vitamin D Leve — View Citation

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 a — View Citation

Chaudhary MFA, Hoffman EA, Guo J, Comellas AP, Newell JD Jr, Nagpal P, Fortis S, Christensen GE, Gerard SE, Pan Y, Wang D, Abtin F, Barjaktarevic IZ, Barr RG, Bhatt SP, Bodduluri S, Cooper CB, Gravens-Mueller L, Han MK, Kazerooni EA, Martinez FJ, Menchaca — View Citation

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 a — View Citation

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 — View Citation

Cooper CB, Paine R, Curtis JL, Kanner RE, Martinez CH, Meldrum CA, Bowler R, O'Neal W, Hoffman EA, Couper D, Quibrera M, Criner G, Dransfield MT, Han MK, Hansel NN, Krishnan JA, Lazarus SC, Peters SP, Barr RG, Martinez FJ, Woodruff PG; SPIROMICS investiga — View Citation

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. — View Citation

DiLillo KM, Norman KC, Freeman CM, Christenson SA, Alexis NE, Anderson WH, Barjaktarevic IZ, Barr RG, Comellas AP, Bleecker ER, Boucher RC, Couper DJ, Criner GJ, Doerschuk CM, Wells JM, Han MK, Hoffman EA, Hansel NN, Hastie AT, Kaner RJ, Krishnan JA, Laba — View Citation

Ejike CO, Woo H, Galiatsatos P, Paulin LM, Krishnan JA, Cooper CB, Couper DJ, Kanner RE, Bowler RP, Hoffman EA, Comellas AP, Criner GJ, Barr RG, Martinez FJ, Han MK, Martinez CH, Ortega VE, Parekh TM, Christenson SA, Thakur N, Baugh A, Belz DC, Raju S, Ga — View Citation

Esther CR Jr, O'Neal WK, Alexis NE, Koch AL, Cooper CB, Barjaktarevic I, Raffield LM, Bowler RP, Comellas AP, Peters SP, Hastie AT, Curtis JL, Ronish B, Ortega VE, Wells JM, Halper-Stromberg E, Rennard SI, Boucher RC; SPIROMICS. Prolonged, physiologically — View Citation

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 Morbi — View Citation

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 — View Citation

Fawzy A, Woo H, Balasubramanian A, Barjaktarevic I, Barr RG, Bowler RP, Comellas AP, Cooper CB, Couper D, Criner GJ, Dransfield MT, Han MK, Hoffman EA, Kanner RE, Krishnan JA, Martinez FJ, McCormack M, Paine Iii R, Peters S, Wise R, Woodruff PG, Hansel NN — View Citation

Fernandez-Baldera A, Hatt CR, Murray S, Hoffman EA, Kazerooni EA, Martinez FJ, Han MK, Galban CJ. Correcting Nonpathological Variation in Longitudinal Parametric Response Maps of CT Scans in COPD Subjects: SPIROMICS. Tomography. 2017 Sep;3(3):138-145. doi — View Citation

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. — View Citation

Galiatsatos P, Woo H, Paulin LM, Kind A, Putcha N, Gassett AJ, Cooper CB, Dransfield MT, Parekh TM, Oates GR, Barr RG, Comellas AP, Han MK, Peters SP, Krishnan JA, Labaki WW, McCormack MC, Kaufman JD, Hansel NN. The Association Between Neighborhood Socioe — View Citation

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 — View Citation

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 cent — View Citation

Gillenwater LA, Kechris KJ, Pratte KA, Reisdorph N, Petrache I, Labaki WW, O'Neal W, Krishnan JA, Ortega VE, DeMeo DL, Bowler RP. Metabolomic Profiling Reveals Sex Specific Associations with Chronic Obstructive Pulmonary Disease and Emphysema. Metabolites — View Citation

Godbole S, Labaki WW, Pratte KA, Hill A, Moll M, Hastie AT, Peters SP, Gregory A, Ortega VE, DeMeo D, Cho MH, Bhatt SP, Wells JM, Barjaktarevic I, Stringer KA, Comellas A, O'Neal W, Kechris K, Bowler RP. A Metabolomic Severity Score for Airflow Obstructio — View Citation

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 positio — View Citation

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 c — View Citation

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. Im — View Citation

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 Revea — View Citation

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, — View Citation

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 — View Citation

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. — View Citation

Hansel NN, Woo H, Koehler K, Gassett A, Paulin LM, Alexis NE, Putcha N, Lorizio W, Fawzy A, Belz D, Sack C, Barr RG, Martinez FJ, Han MK, Woodruff P, Pirozzi C, Paine R 3rd, Barjaktarevic I, Cooper CB, Ortega V, Zusman M, Kaufman JD. Indoor Pollution and — View Citation

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 D — View Citation

Hill AC, Guo C, Litkowski EM, Manichaikul AW, Yu B, Konigsberg IR, Gorbet BA, Lange LA, Pratte KA, Kechris KJ, DeCamp M, Coors M, Ortega VE, Rich SS, Rotter JI, Gerzsten RE, Clish CB, Curtis JL, Hu X, Obeidat ME, Morris M, Loureiro J, Ngo D, O'Neal WK, Me — View Citation

Hobbs BD, de Jong K, Lamontagne M, Bosse 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, — View Citation

Iyer AS, Parekh TM, O'Toole J, Bhatt SP, Eakin MN, Krishnan JA, Yohannes AM, Woodruff PG, Cooper CB, Kanner RE, Hanania NA, Dransfield MT, Regan EA, Hoth KF, Kim V; COPDGene and SPIROMICS Investigators. Clinically Significant and Comorbid Anxiety and Depr — View Citation

Izquierdo M, Marion CR, Genese F, Newell JD, O'Neal WK, Li X, Hawkins GA, Barjaktarevic I, Barr RG, Christenson S, Cooper CB, Couper D, Curtis J, Han MK, Hansel NN, Kanner RE, Martinez FJ, Paine R 3rd, Tejwani V, Woodruff PG, Zein JG, Hoffman EA, Peters S — View Citation

Kasela S, Ortega VE, Martorella M, Garudadri S, Nguyen J, Ampleford E, Pasanen A, Nerella S, Buschur KL, Barjaktarevic IZ, Barr RG, Bleecker ER, Bowler RP, Comellas AP, Cooper CB, Couper DJ, Criner GJ, Curtis JL, Han MK, Hansel NN, Hoffman EA, Kaner RJ, K — View Citation

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 Inves — View Citation

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'Ne — View Citation

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(1 — View Citation

Koch AL, Shing TL, Namen A, Couper D, Smith B, Barr RG, Bhatt S, Putcha N, Baugh A, Saha AK, Ziedler M, Comellas A, Cooper CB, Barjaktarevic I, Bowler RP, Han MK, Kim V, Paine R 3rd, Kanner RE, Krishnan JA, Martinez FJ, Woodruff PG, Hansel NN, Hoffman EA, — View Citation

Krishnan JK, Ancy KM, Oromendia C, Hoffman KL, Easthausen I, Leidy NK, Han MK, Bowler RP, Christenson SA, Couper DJ, Criner GJ, Curtis JL, Dransfield MT, Hansel NN, Iyer AS, Paine Iii R, Peters SP, Wedzicha JA, Woodruff PG, Ballman KV, Martinez FJ; SPIROM — View Citation

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, Stringe — View Citation

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 M — View Citation

LaFon DC, Woo H, Fedarko N, Azar A, Hill H, Tebo AE, Martins TB, Han MK, Krishnan JA, Ortega VE, Barjaktarevic I, Kaner RJ, Hastie A, O'Neal WK, Couper D, Woodruff PG, Curtis JL, Hansel NN, Nahm MH, Dransfield MT, Putcha N; SPIROMICS investigators. Reduce — View Citation

Lakshman Kumar P, Wilson AC, Rocco A, Cho MH, Wan E, Hobbs BD, Washko GR, Ortega VE, Christenson SA, Li X, Wells JM, Bhatt SP, DeMeo DL, Lutz SM, Rossiter H, Casaburi R, Rennard SI, Lomas DA, Labaki WW, Tal-Singer R, Bowler RP, Hersh CP, Tiwari HK, Dransf — View Citation

LeMaster WB, Quibrera PM, Couper D, Tashkin DP, Bleecker ER, Doerschuk CM, Ortega VE, Cooper C, Han MK, Woodruff PG, O'Neal WK, Anderson WH, Alexis NE, Bowler RP, Barr RG, Kaner RJ, Dransfield MT, Paine R 3rd, Kim V, Curtis JL, Martinez FJ, Hastie AT, Bar — View Citation

Li F, Choi J, Zou C, Newell JD Jr, Comellas AP, Lee CH, Ko H, Barr RG, Bleecker ER, Cooper CB, Abtin F, Barjaktarevic I, Couper D, Han M, Hansel NN, Kanner RE, Paine R 3rd, Kazerooni EA, Martinez FJ, O'Neal W, Rennard SI, Smith BM, Woodruff PG, Hoffman EA — View Citation

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. G — View Citation

Madapoosi SS, Cruickshank-Quinn C, Opron K, Erb-Downward JR, Begley LA, Li G, Barjaktarevic I, Barr RG, Comellas AP, Couper DJ, Cooper CB, Freeman CM, Han MK, Kaner RJ, Labaki W, Martinez FJ, Ortega VE, Peters SP, Paine R, Woodruff P, Curtis JL, Huffnagle — View Citation

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 Invest — View Citation

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-Relate — View Citation

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, Ren — View Citation

McKleroy W, Shing T, Anderson WH, Arjomandi M, Awan HA, Barjaktarevic I, Barr RG, Bleecker ER, Boscardin J, Bowler RP, Buhr RG, Criner GJ, Comellas AP, Curtis JL, Dransfield M, Doerschuk CM, Dolezal BA, Drummond MB, Han MK, Hansel NN, Helton K, Hoffman EA — View Citation

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 Sm — View Citation

Motahari A, Barr RG, Han MK, Anderson WH, Barjaktarevic I, Bleecker ER, Comellas AP, Cooper CB, Couper DJ, Hansel NN, Kanner RE, Kazerooni EA, Lynch DA, Martinez FJ, Newell JD Jr, Schroeder JD, Smith BM, Woodruff PG, Hoffman EA; SPIROMICS Group. Repeatabi — View Citation

Moughames E, Woo H, Galiatsatos P, Romero-Rivero K, Raju S, Tejwani V, Hoffman EA, Comellas AP, Ortega VE, Parekh T, Krishnan JA, Drummond MB, Couper D, Buhr RG, Paine R, Kaufman JD, Paulin LM, Putcha N, Hansel NN. Disparities in access to food and chroni — View Citation

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 — View Citation

O'Toole J, Woo H, Putcha N, Cooper CB, Woodruff P, Kanner RE, Paine R, Bowler RP, Comellas A, Hoth KF, Krishnan JA, Han M, Dransfield M, Iyer AS, Couper D, Peters SP, Criner G, Kim V, Barr RG, Martinez FJ, Hansel NN, Eakin MN; SPIROMICS Investigators. Com — View Citation

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 — View Citation

Oh AL, Mularski RA, Barjaktarevic I, Barr RG, Bowler RP, Comellas AP, Cooper CB, Criner GJ, Han MK, Hansel NN, Hoffman EA, Kanner RE, Krishnan JA, Paine R 3rd, Parekh TM, Peters SP, Christenson SA, Woodruff PG; SPIROMICS Smoking Resilience Group. Defining — View Citation

Opron K, Begley LA, Erb-Downward JR, Freeman C, Madapoosi S, Alexis NE, Barjaktarevic I, Graham Barr R, Bleecker ER, Bowler RP, Christenson SA, Comellas AP, Cooper CB, Couper DJ, Doerschuk CM, Dransfield MT, Han MK, Hansel NN, Hastie AT, Hoffman EA, Kaner — View Citation

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, Meye — View Citation

Pan Y, Wang D, Chaudhary MFA, Shao W, Gerard SE, Durumeric OC, Bhatt SP, Barr RG, Hoffman EA, Reinhardt JM, Christensen GE. Robust Measures of Image-Registration-Derived Lung Biomechanics in SPIROMICS. J Imaging. 2022 Nov 16;8(11):309. doi: 10.3390/jimagi — View Citation

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 pulmo — View Citation

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, Ha — View Citation

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 Tomo — View Citation

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 SubPopu — View Citation

Pratte KA, Curtis JL, Kechris K, Couper D, Cho MH, Silverman EK, DeMeo DL, Sciurba FC, Zhang Y, Ortega VE, O'Neal WK, Gillenwater LA, Lynch DA, Hoffman EA, Newell JD Jr, Comellas AP, Castaldi PJ, Miller BE, Pouwels SD, Hacken NHTT, Bischoff R, Klont F, Wo — View Citation

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 i — View Citation

Putcha N, Fawzy A, Matsui EC, Liu MC, Bowler RP, Woodruff PG, O'Neal WK, Comellas AP, Han MK, Dransfield MT, Wells JM, Lugogo N, Gao L, Talbot CC Jr, Hoffman EA, Cooper CB, Paulin LM, Kanner RE, Criner G, Ortega VE, Barr RG, Krishnan JA, Martinez FJ, Drum — View Citation

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 — View Citation

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 seru — View Citation

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. — View Citation

Radicioni G, Ceppe A, Ford AA, Alexis NE, Barr RG, Bleecker ER, Christenson SA, Cooper CB, Han MK, Hansel NN, Hastie AT, Hoffman EA, Kanner RE, Martinez FJ, Ozkan E, Paine R 3rd, Woodruff PG, O'Neal WK, Boucher RC, Kesimer M. Airway mucin MUC5AC and MUC5B — View Citation

Ronish BE, Couper DJ, Barjaktarevic IZ, Cooper CB, Kanner RE, Pirozzi CS, Kim V, Wells JM, Han MK, Woodruff PG, Ortega VE, Peters SP, Hoffman EA, Buhr RG, Dolezal BA, Tashkin DP, Liou TG, Bateman LA, Schroeder JD, Martinez FJ, Barr RG, Hansel NN, Comellas — View Citation

Ryu MH, Yun JH, Morrow JD, Saferali A, Castaldi P, Chase R, Stav M, Xu Z, Barjaktarevic I, Han M, Labaki W, Huang YJ, Christenson S, O'Neal W, Bowler R, Sin DD, Freeman CM, Curtis JL, Hersh CP. Blood Gene Expression and Immune Cell Subtypes Associated wit — View Citation

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. doi: 10.1164/rccm.201506-1208PP. — View Citation

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 Ather — View Citation

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 J — View Citation

Sowho MO, Koch AL, Putcha N, Woo H, Gassett A, Paulin LM, Koehler K, Barr RG, Comellas AP, Cooper CB, Barjaktarevic I, Zeidler MR, Billings ME, Bowler RP, Han MK, Kim V, Paine Iii R, Parekh TM, Krishnan JA, Peters SP, Woodruff PG, Baugh AM, Kaufman JD, Co — View Citation

Stott-Miller M, Mullerova H, Miller B, Tabberer M, El Baou C, Keeley T, Martinez FJ, Han M, Dransfield M, Hansel NN, Cooper CB, Woodruff P, Ortega VE, Comellas AP, Paine Iii R, Kanner RE, Anderson W, Drummond MB, Kim V, Tal-Singer R, Lazaar AL. Defining C — View Citation

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, Doersc — View Citation

Tejwani V, Woo H, Liu C, Tillery AK, Gassett AJ, Kanner RE, Hoffman EA, Martinez FJ, Woodruff PG, Barr RG, Fawzy A, Koehler K, Curtis JL, Freeman CM, Cooper CB, Comellas AP, Pirozzi C, Paine R, Tashkin D, Krishnan JA, Sack C, Putcha N, Paulin LM, Zusman M — View Citation

Turnier L, Eakin M, Woo H, Dransfield M, Parekh T, Krishnan JA, Kanner R, Cooper CB, Woodruff PG, Wise R, Han MK, Romero K, Paulin LM, Peters S, Drummond B, Bleecker ER, Bowler R, Comellas AP, Couper D, Paine R, Martinez F, Barr G, Putcha N, Hansel NN. Th — View Citation

Van Buren E, Radicioni G, Lester S, O'Neal WK, Dang H, Kasela S, Garudadri S, Curtis JL, Han MK, Krishnan JA, Wan ES, Silverman EK, Hastie A, Ortega VE, Lappalainen T, Nawijn MC, Berge MVD, Christenson SA, Li Y, Cho MH, Kesimer M, Kelada SNP. Genetic regu — View Citation

Wang D, Pan Y, Durumeric OC, Reinhardt JM, Hoffman EA, Schroeder JD, Christensen GE. PLOSL: Population learning followed by one shot learning pulmonary image registration using tissue volume preserving and vesselness constraints. Med Image Anal. 2022 Jul; — View Citation

Wang JM, Labaki WW, Murray S, Martinez FJ, Curtis JL, Hoffman EA, Ram S, Bell AJ, Galban CJ, Han MK, Hatt C. Machine learning for screening of at-risk, mild and moderate COPD patients at risk of FEV1 decline: results from COPDGene and SPIROMICS. Front Phy — View Citation

Weiss JR, Serdenes R, Madtha U, Zhao H, Kim V, Lopez-Pastrana J, Eakin MN, O'Toole J, Cooper CB, Woodruff P, Kanner RE, Krishnan JA, Iyer AS, Couper D, Morrison MF. Association Among Chronic Obstructive Pulmonary Disease Severity, Exacerbation Risk, and A — View Citation

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, C — View Citation

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 an — View Citation

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-pr — View Citation

Wendt CH, Bowler RP, Demorest C, Hastie A, Labaki WW, Chen M, Carmella SG, Hecht SS. Levels of Urinary Mercapturic Acids of Acrolein, Methacrolein, Crotonaldehyde, and Methyl Vinyl Ketone in Relationship to Chronic Obstructive Pulmonary Disease in Cigaret — View Citation

Woo H, Brigham EP, Allbright K, Ejike C, Galiatsatos P, Jones MR, Oates GR, Krishnan JA, Cooper CB, Kanner RE, Bowler RP, Hoffman EA, Comellas AP, Criner G, Barr RG, Martinez FJ, Han M, Ortega VE, Parekh TM, Christenson S, Belz D, Raju S, Gassett A, Pauli — View Citation

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 Sympto — View Citation

Yee N, Markovic D, Buhr RG, Fortis S, Arjomandi M, Couper D, Anderson WH, Paine R 3rd, Woodruff PG, Han MK, Martinez FJ, Barr RG, Wells JM, Ortega VE, Hoffman EA, Kim V, Drummond MB, Bowler RP, Curtis JL, Cooper CB, Tashkin DP, Barjaktarevic IZ. Significa — View Citation

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 amo — View Citation

Zhang WZ, Hoffman KL, Schiffer KT, Oromendia C, Rice MC, Barjaktarevic I, Peters SP, Putcha N, Bowler RP, Wells JM, Couper DJ, Labaki WW, Curtis JL, Han MK, Paine R 3rd, Woodruff PG, Criner GJ, Hansel NN, Diaz I, Ballman KV, Nakahira K, Choi ME, Martinez — View Citation

Zhang WZ, Oromendia C, Kikkers SA, Butler JJ, O'Beirne S, Kim K, O'Neal WK, Freeman CM, Christenson SA, Peters SP, Wells JM, Doerschuk C, Putcha N, Barjaktarevic I, Woodruff PG, Cooper CB, Bowler RP, Comellas AP, Criner GJ, Paine R 3rd, Hansel NN, Han MK, — View Citation

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, C — View Citation

Zou C, Li F, Choi J, Haghighi B, Choi S, Rajaraman PK, Comellas AP, Newell JD, Lee CH, Barr RG, Bleecker E, Cooper CB, Couper D, Han M, Hansel NN, Kanner RE, Kazerooni EA, Kleerup EC, Martinez FJ, O'Neal W, Paine R 3rd, Rennard SI, Smith BM, Woodruff PG, — View Citation

* Note: There are 114 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Morbidity in SPIROMICS will primarily be measured by assessing acute exacerbations in the SPIROMICS cohort.	Up to end of follow-up (data presented up to month 36)
Primary	Lung Function	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.	Up to end of follow-up (data presented up to month 36)
Primary	Mortality	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.	Up to end of follow-up (data presented up to month 36)
Secondary	Repeatability Substudy: Repeatability of clinic visit measurements	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.	Up to end of recruitment (2-6 week measurement repeatability)
Secondary	Exacerbation Substudy: Assess clinical and biological data in relation to an acute exacerbation	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.	Up to end of follow-up (data presented up to month 15)
Secondary	Exacerbation Substudy: Assess symptomatic changes in COPD in relation to acute exacerbation	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.	Up to end of follow-up (data presented up to month 15)
Secondary	Parametric Response Mapping in COPD: Structural assessment of the lung	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.	Up to end of follow-up (data presented up to month 36)

External Links

•   Study Website