Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease characterised by progressive airflow limitation. It affects approximately 1.2 million people in the UK, is the fifth leading cause of death in the UK and costs the NHS approximately £1 billion annually. Exacerbations of COPD account for 60% of NHS COPD costs and are associated with accelerated rate of lung function decline, reduced physical activity, reduced quality of life, increased mortality and increased risk of comorbidities such as acute myocardial infarction and stroke. Observational studies consistently report that beta-blocker use in people with COPD is associated with a reduced risk of COPD exacerbations. This beneficial association with exacerbations extends to people with COPD without cardiovascular disease and appears to be class specific. This pragmatic prospective double blind randomised trial will formally test whether a beta-blocker reduces the incidence of exacerbations in people with COPD. The BICS trial, funded by the NIHR HTA programme, is a national multi-centre randomised controlled trial which aims to determine the clinical effectiveness and cost-effectiveness of adding bisoprolol (maximal dose 5mg once a day, or maximum tolerated dose) to usual COPD therapies in patients with COPD at high risk of exacerbation. The initial recruitment target was 1574 participants, half from primary care. Patients will be randomised to bisoprolol or placebo for one year. The primary clinical outcome is the number of participant reported COPD exacerbations necessitating a change in management (minimum change treatment with antibiotics and/or oral corticosteroids) during the one year treatment period. The BICS study is led by Professor Graham Devereux (University of Aberdeen/Liverpool School of Tropical Medicine) and Professor Brian Lipworth (University of Dundee). BICS opened to recruitment in September 2018. Recruitment was paused between March 2020 and August 2021 due to the COVID-19 pandemic and was terminated in May 2022 before the recruitment target was met.
515 participants were included. The mean age was 68 years (standard deviation 7.9 years), and 53% were men. We had primary outcome data available for 514 patients (99.8%). In the bisoprolol group, there were 526 patient reported COPD exacerbations treated with oral corticosteroids, antibiotics – a mean exacerbation rate of 2.03 per year. In the placebo group, there were 513 exacerbations – a mean exacerbation rate of 2.01 per year. The adjusted incidence rate ratio was 0.97 (95% CI, 0.84-1.13; p=0.72). Serious adverse events occurred in 37 of 255 patients in the bisoprolol group (14.5%) vs 36 of 251 in the placebo group (14.3%; relative risk, 1.01; 95% CI, 0.62-1.66; p=0.96).
The results have been published in JAMA.
Contacts
- Seonaidh Cotton; s.c.cotton@abdn.ac.uk
Status
CompletedPublications
Cotton, S., Devereux, G., Abbas, H. et al. 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, 307 (2022). https://doi.org/10.1186/s13063-022-06226-8
Devereux G, Cotton S, Nath M, et al. Bisoprolol in Patients With Chronic Obstructive Pulmonary Disease at High Risk of Exacerbation: The BICS Randomized Clinical Trial. JAMA. Published online May 19, 2024. doi:10.1001/jama.2024.8771