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 (5mg bisoprolol) over four-seven 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.
We are grateful for the secretarial and data co-ordination support from Janice Cruden. We would like to acknowledge the principal investigators and staff based in trial recruitment sites across the country, the Clinical Research Networks and staff in the Clinical Trials Pharmacy, and the support of the Trial Steering and Data Monitoring Committees. In particular, we have been grateful for the input to the Trial Steering Committee from two lay representatives,
Mr Alister Laird and Mr Dave Bertin.
This project was funded by the National Institute for Health Research, Health Technology Assessment Programme (project number 15/130/20). The cardiac sub-study is funded by British Heart Foundation (BHF) Project Grant no. PG/17/64/33205. This report presents independent research commissioned by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health
Technology Assessment programme or the Department of Health.
- randomised controlled trial
- beta blocker
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Data from: 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)
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