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Chronic obstructive pulmonary disease
Design of the Subpopulations and Intermediate Outcome Measures in COPD (SPIROMICS) AIR Study
  1. Nadia N Hansel1,
  2. Laura M Paulin1,
  3. Amanda J Gassett2,
  4. Roger D Peng3,
  5. Neil Alexis4,
  6. Vincent S Fan2,5,
  7. Eugene Bleecker6,
  8. Russell Bowler7,
  9. Alejandro P Comellas8,
  10. Mark Dransfield9,
  11. MeiLan K Han10,
  12. Victor Kim11,
  13. Jerry A Krishnan12,
  14. Cheryl Pirozzi13,
  15. Christopher B Cooper14,
  16. Fernando Martinez15,
  17. Prescott G Woodruff16,
  18. Patrick J Breysse17,
  19. R Graham Barr18 and
  20. Joel D Kaufman2
  1. 1 Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  2. 2 University of Washington, Seattle, Washington, USA
  3. 3 Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  4. 4 University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
  5. 5 VA Puget Sound Health Care System, Seattle, Washington, USA
  6. 6 Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
  7. 7 National Jewish Health, Denver, Colorado, USA
  8. 8 University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
  9. 9 University of Alabama at Birmingham, Birmingham, Alabama, USA
  10. 10 University of Michigan School of Medicine, Ann Arbor, Michigan, USA
  11. 11 Temple University School of Medicine, Philadelphia, Pennsylvania, USA
  12. 12 University of Illinois, Chicago, Illinois, USA
  13. 13 University of Utah Health Sciences Center, Salt Lake City, Utah, USA
  14. 14 University of California Los Angeles, Los Angeles, California, USA
  15. 15 Weill Medical College, New York City, New York, USA
  16. 16 University of California San Francisco School of Medicine, San Francisco, California, USA
  17. 17 National Center for Environmental Health/Agency for Toxic Substances & Disease Registry, Atlanta, Georgia, USA
  18. 18 Columbia University Medicine Center, New York, USA
  1. Correspondence to Dr Nadia N Hansel; nhansel1{at}jhmi.edu

Abstract

Introduction Population-based epidemiological evidence suggests that exposure to ambient air pollutants increases hospitalisations and mortality from chronic obstructive pulmonary disease (COPD), but less is known about the impact of exposure to air pollutants on patient-reported outcomes, morbidity and progression of COPD.

Methods and analysis The Subpopulations and Intermediate Outcome Measures in COPD (SPIROMICS) Air Pollution Study (SPIROMICS AIR) was initiated in 2013 to investigate the relation between individual-level estimates of short-term and long-term air pollution exposures, day-to-day symptom variability and disease progression in individuals with COPD. SPIROMICS AIR builds on a multicentre study of smokers with COPD, supplementing it with state-of-the-art air pollution exposure assessments of fine particulate matter, oxides of nitrogen, ozone, sulfur dioxide and black carbon. In the parent study, approximately 3000 smokers with and without airflow obstruction are being followed for up to 3 years for the identification of intermediate biomarkers which predict disease progression. Subcohorts undergo daily symptom monitoring using comprehensive daily diaries. The air monitoring and modelling methods employed in SPIROMICS AIR will provide estimates of individual exposure that incorporate residence-specific infiltration characteristics and participant-specific time-activity patterns. The overarching study aim is to understand the health effects of short-term and long-term exposures to air pollution on COPD morbidity, including exacerbation risk, patient-reported outcomes and disease progression.

Ethics and dissemination The institutional review boards of all the participating institutions approved the study protocols. The results of the trial will be presented at national and international meetings and published in peer-reviewed journals.

  • COPD epidemiology
  • emphysema

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjresp-2017-000186

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    Footnotes

    • Contributors NNH, JDK, RDP, VSF, PJB, RGB and NA contributed to study design and drafting and review of the manuscript. AJG and LMP contributed to data collection, drafting and review of the manuscript. All other coauthors EB, RB, APC, MD, MKH, VK, JAK, CP, CBC, FM and PGW contributed to data collection and manuscript review.

    • Funding SPIROMICS AIR was supported by NIH NIEHS (R01ES023500). SPIROMICS was supported by contracts from the NIH/NHLBI (HHSN268200900013C, HHSN268200900014C, HHSN268200900015C, HHSN268200900016C, HHSN268200900017C, HHSN268200900018C, HHSN268200900019C, HHSN268200900020C), which were supplemented by contributions made through the Foundation for the NIH from AstraZeneca; Bellerophon Therapeutics; Boehringer-Ingelheim Pharmaceuticals, Inc; Chiesi Farmaceutici SpA; Forest Research Institute, Inc; GSK; Grifols Therapeutics, Inc; Ikaria, Inc; Nycomed GmbH; Takeda Pharmaceutical Company; Novartis Pharmaceuticals Corporation; Regeneron Pharmaceuticals, Inc; and Sanofi.

    • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: NNH has research grants from NIH/NIEHS and EPA, research grants and personal fees (advisory board) from AstraZeneca and GlaxoSmithKline; LMP and AJG have grants from NIH; RDP has personal fees from the Health Effects Institute; EB has grants from NHLBI/NIH, personal fees from consultancy and is involved in clinical trials administered through Wake Forest School of Medicine from Amgen, AstraZeneca-MedImmune, Boehringer-Ingelheim, Genentech/Roche, GlaxoSmithKline, Novartis and Sanofi/Regeneron, personal fees from Knopp, and clinical trials administered through Wake Forest School of Medicine from Janssen/Johnson & Johnson, Pfizer and Teva; APC has non-financial support for consultancy through VIDA Diagnostics; MD has grants from NIH and the Department of Defense and personal fees for consultancy from AstraZeneca; MKH has personal fees from Boehringer-Ingelheim, Novartis, AstraZeneca, GlaxoSmithKline and Sunovian; VK has personal fees from Medscape (peer reviewer), CSA Medical (advisory board), American Board of Internal Medicine (Critical Care Medicine Committee chair), Gala Therapeutics (advisory board) and PneumRx; JAK has grants from NIH/NHLBI; CBC has grants and personal fees from Equinox Health Clubs and Spiration, a grant from Amgen, and personal fees from PulmonX, Boehringer-Ingelheim and GlaxoSmithKline; FM has a grant from NHLBI; PGW has a grant from MedImmune and personal fees from Genentech/Roche, AstraZeneca, Novartis, Neostem and Janseen for consultancy; RGB has grants from NIH, Foundation for the NIH and COPD Foundation; NA, VSF, RB, CP, PJB and JDK have nothing to disclose.

    • Patient consent Obtained.

    • Ethics approval Institutional Review Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.