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).
Author
Cotton, SeonaidhDevereux, 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
Publication date
2022-04-14
Metadata
Show full item recordAbstract
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, Choudhury G, Dawson D, De Soyza A, Fielding S, Gompertz S, Haughney J, Lang CC, Lee AJ, MacLennan G, MacNee W, McCormack K, McMeekin N, Mills NL, Morice A, Norrie J, Petrie MC, Price D, Short P, Vestbo J, Walker P, Wedzicha J, Wilson A, Lipworth BJ. 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. 2022 Apr 14;23(1):307. doi: 10.1186/s13063-022-06226-8Type
ArticleAdditional Links
https://trialsjournal.biomedcentral.com/PMID
35422024Journal
TrialsPublisher
BioMed Centralae974a485f413a2113503eed53cd6c53
10.1186/s13063-022-06226-8