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Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS)

Cotton, Seonaidh; Devereux, Graham; Abbas, Hassan; Briggs, Andrew; Campbell, Karen; Chaudhuri, Rekha; Choudhury, Gourab; Dawson, Dana; De Soyza, Anthony; Fielding, Shona; Gompertz, Simon; Haughney, John; Lang, Chim C.; Lee, Amanda J.; MacLennan, Graeme; MacNee, William; McCormack, Kirsty; McMeekin, Nicola; Mills, Nicholas L.; Morice, Alyn; Norrie, John; Petrie, Mark C.; Price, David; Short, Philip; Vestbo, Jorgen; Walker, Paul; Wedzicha, Jadwiga; Wilson, Andrew; Lipworth, Brian J.

Authors

Seonaidh Cotton

Graham Devereux

Hassan Abbas

Andrew Briggs

Karen Campbell

Rekha Chaudhuri

Gourab Choudhury

Dana Dawson

Anthony De Soyza

Shona Fielding

Simon Gompertz

John Haughney

Chim C. Lang

Amanda J. Lee

Graeme MacLennan

William MacNee

Kirsty McCormack

Nicola McMeekin

Nicholas L. Mills

John Norrie

Mark C. Petrie

David Price

Philip Short

Jorgen Vestbo

Paul Walker

Jadwiga Wedzicha

Andrew Wilson

Brian J. Lipworth



Abstract

Background: Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity, mortality and healthcare costs. Beta blockers are well-established drugs widely used to treat cardiovascular conditions. Observational studies consistently report that beta blocker use in people with COPD is associated with a reduced risk of COPD exacerbations. The bisoprolol in COPD study (BICS) investigates whether adding bisoprolol to routine COPD treatment has clinical and cost-effective benefits. A sub-study will risk stratify participants for heart failure to investigate whether any beneficial effect of bisoprolol is restricted to those with unrecognised heart disease. Methods: BICS is a pragmatic randomised parallel group double-blind placebo-controlled trial conducted in UK primary and secondary care sites. The major inclusion criteria are an established predominant respiratory diagnosis of COPD (post-bronchodilator FEV1 < 80% predicted, FEV1/FVC < 0.7), a self-reported history of ≥ 2 exacerbations requiring treatment with antibiotics and/or oral corticosteroids in a 12-month period since March 2019, age ≥ 40 years and a smoking history ≥ 10 pack years. A computerised randomisation system will allocate 1574 participants with equal probability to intervention or control groups, stratified by centre and recruitment in primary/secondary care. The intervention is bisoprolol (1.25 mg tablets) or identical placebo. The dose of bisoprolol/placebo is titrated up to a maximum of 4 tablets a day (5 mg bisoprolol) over 4–7 weeks depending on tolerance to up-dosing of bisoprolol/placebo—these titration assessments are completed by telephone or video call. Participants complete the remainder of the 52-week treatment period on the final titrated dose (1, 2, 3, 4 tablets) and during that time are followed up at 26 and 52 weeks by telephone or video call. The primary outcome is the total number of participant reported COPD exacerbations requiring oral corticosteroids and/or antibiotics during the 52-week treatment period. A sub-study will risk stratify participants for heart failure by echocardiography and measurement of blood biomarkers. Discussion: The demonstration that bisoprolol reduces the incidence of exacerbations would be relevant not only to patients and clinicians but also to healthcare providers, in the UK and globally. Trial registration: Current controlled trials ISRCTN10497306. Registered on 16 August 2018

Citation

Cotton, S., Devereux, G., Abbas, H., Briggs, A., Campbell, K., Chaudhuri, R., …Lipworth, B. J. (2022). Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS). Trials, 23(1), Article 307. https://doi.org/10.1186/s13063-022-06226-8

Journal Article Type Article
Acceptance Date Mar 26, 2022
Online Publication Date Apr 14, 2022
Publication Date Dec 1, 2022
Deposit Date May 5, 2022
Publicly Available Date Oct 27, 2022
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 23
Issue 1
Article Number 307
DOI https://doi.org/10.1186/s13063-022-06226-8
Keywords COPD; Exacerbation; Randomised controlled trial; Bisoprolol; Beta blocker
Public URL https://hull-repository.worktribe.com/output/3985510

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Publisher Licence URL
http://creativecommons.org/licenses/by/4.0

Copyright Statement
© The Author(s). 2022.
Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.





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