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  • Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD

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Respiratory medicine
Protocol
Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD
  1. Allison Martin1,2,
  2. Robert J Hancox3,
  3. Catherina L Chang4,
  4. Richard Beasley5,
  5. Jeremy Wrobel6,7,
  6. Vanessa McDonald8,9,
  7. Claudia C Dobler1,2,10,
  8. Ian A Yang11,12,
  9. Claude S Farah13,
  10. Belinda Cochrane14,15,
  11. Graham S Hillis16,17,
  12. Caroline Polak Scowcroft18,
  13. Ashutosh Aggarwal19,
  14. Gian Luca Di Tanna1,2,
  15. Grace Balicki1,2,
  16. Shane Galgey1,2,
  17. Christine Jenkins1,2
  1. 1The George Institute for Global Health, Newtown, New South Wales, Australia
  2. 2University of New South Wales, Sydney, New South Wales, Australia
  3. 3University of Otago, Dunedin, New Zealand
  4. 4Waikato Hospital, Hamilton, New Zealand
  5. 5Medical Research Institute of New Zealand, Wellington, New Zealand
  6. 6Fiona Stanley Hospital, Murdoch, Western Australia, Australia
  7. 7The University of Notre Dame Australia, Fremantle, Western Australia, Australia
  8. 8University of Newcastle, Callaghan, New South Wales, Australia
  9. 9John Hunter Hospital, New Lambton Heights, New South Wales, Australia
  10. 10Liverpool Hospital, Liverpool, New South Wales, Australia
  11. 11The Prince Charles Hospital, Chermside, Queensland, Australia
  12. 12The University of Queensland, Saint Lucia, Queensland, Australia
  13. 13Concord Repatriation General Hospital, Concord, New South Wales, Australia
  14. 14Campbelltown Hospital, Campbelltown, New South Wales, Australia
  15. 15Western Sydney University, Penrith, NSW, Australia
  16. 16Royal Perth Hospital, Perth, Western Australia, Australia
  17. 17The University of Western Australia, Perth, Western Australia, Australia
  18. 18Consumer Representative, Canberra, ACT, Australia
  19. 19Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
  1. Correspondence to Dr Allison Martin; ahumphries{at}georgeinstitute.org.au

Abstract

Introduction Heart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (β)-blockers. There is observational evidence that cardioselective β-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective β-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective β-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity.

Methods and analyses This is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25–5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months.

The study will enrol 1164 participants with moderate to severe COPD, aged 40–85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV1) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months.

Ethics and dissemination The study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital.

Trial registration numbers NCT03917914; CTRI/2020/08/027322.

  • chronic airways disease
  • heart failure
  • myocardial infarction
  • stroke
http://creativecommons.org/licenses/by-nc/4.0/

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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2021-053446

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    Footnotes

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    • Contributors All authors listed are either members of the PACE Steering Committee or the Coordinating Team and have met regularly to discuss the design of the study and the writing of the study protocol. CJ, RJH, CLC, RB, JW, VM, CCD, IAY, CSF, BC, GH, CPS, AA and AM are members of the PACE Steering Committee and are responsible for the study design, analysis, interpretation of results and writing reports and publications. CJ, AM, GB, SG are all members of the operational study team and are responsible for trial management and planning, safety, monitoring, document creation and implementation and data acquisition. CLC, RB, JW, VM, CCD, IAY, CSF, BC, AA are all site principal investigators and will be responsible for recruitment and retention of trial participants. GLDT is the senior study statistician who assisted with writing the protocol and has oversight over the development of the statistical analysis plan and final analysis of the results. CSP is our consumer representative. GH is responsible for the cardiovascular oversight of the trial design and implementation. All authors have reviewed this protocol manuscript and provided input into its content.

    • Funding This study is funded by the National Health and Medical Research Council (NHMRC) of Australia, Project Grant APP1163143 and the Health Research Council of New Zealand, Project Grant 19/487.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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    © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.