Bisoprolol in COPD study (BICS)
Research type
Research Study
Full title
A randomised, double-blind placebo controlled trial of the effectiveness of the beta-blocker bisoprolol in preventing exacerbations of chronic obstructive pulmonary disease.
IRAS ID
242190
Contact name
Professor Graham Devereux
Contact email
Sponsor organisation
University of Aberdeen
Eudract number
2017-002779-24
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Research Summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease characterised by worsening airflow limitation. In the UK, 1.2 million people have COPD, 30,000 people die from COPD annually and COPD costs the NHS £1 billion annually. Sudden deteriorations in symptoms (exacerbations) are an important feature of COPD they account for 60% of NHS COPD costs and they reduce life expectancy and quality of life.Beta-blockers are drugs widely used to treat blood pressure and heart disease. Non-heart specialists are often unwilling to prescribe beta-blockers to COPD patients because older beta-blockers had lung side effects. However, evidence shows that newer beta-blockers targeting the heart, e.g. bisoprolol, are safe in COPD. In addition, COPD patients who take beta-blockers appear to experience fewer exacerbations.
In this study we will determine the clinical effectiveness and cost effectiveness of adding bisoprolol to usual COPD treatment in patients with COPD. The primary outcome is the number of exacerbations. The primary economic outcome is the cost per QALY gained during the one year treatment period.
We will recruit 1574 participants from primary and secondary care across the UK. Participants will be randomised to bisoprolol (maximum dose 5mg a day) or placebo (maximum dose 4 tablets a day) for 12 months. To establish the best dose of bisoprolol (and placebo) for each participant we will slowly build up the dose over 4 weeks.
We will follow participants up at six and twelve months to assess the number of exacerbations. We will also collect data on adverse events, health care utilisation, quality of life, breathlessness, and lung function.
Bisoprolol is cheap (4p/day) and, if shown to reduce the risk of COPD exacerbations in a cost effective manner, it will improve the quality of life of COPD patients and reduce the burden of COPD on the NHS.
Summary of Results
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease causing shortness of breath. It has no cure and is a leading cause of death. It affects about 1.2 million people in the UK and costs the NHS around £1.9 billion each year. People with COPD often have symptom “flare-ups” (exacerbations) that usually need emergency treatment and impact quality of life.Bisoprolol is a beta-blocker usually used to treat cardiovascular diseases such as high blood pressure and heart failure. In observational research, people with COPD who take beta-blockers have been reported to have a reduced chance of having exacerbations. The Bisoprolol in COPD Study (BICS) tested whether adding bisoprolol to usual COPD treatments reduced exacerbations in people with COPD.
A total of 515 people with COPD from 76 hospitals and GP practices across the UK took part in BICS. They were randomly divided into two groups: one group (259 people) took bisoprolol every day and the other group (256 people) took dummy placebo pills. People did not know which group they were in. We followed people for up to 12 months and counted how many exacerbations they had. In both groups, people had, on average, two exacerbations in 12 months. There was no difference between the groups – so bisoprolol did not reduce the number of exacerbations that people had. The bisoprolol group did not have any more serious adverse events or respiratory side-effects than the placebo group.
The COVID-19 pandemic had a big impact on the BICS study: we planned to recruit 1574 patients but were only able to recruit 515. Nevertheless, the results from the BICS study are important. Although bisoprolol did not reduce exacerbations, it was safe for patients with COPD. This important finding means that bisoprolol can be used to treat cardiovascular diseases in patients who have COPD.
REC name
Scotland B REC
REC reference
18/SS/0033
Date of REC Opinion
22 May 2018
REC opinion
Further Information Favourable Opinion