People with chronic obstructive pulmonary disease (COPD) are being asked to participate in a U.K. clinical study evaluating how well bisoprolol, a common beta-blocker to treat high blood pressure, works in preventing pulmonary flares.
Known as the BICS trial (2017-002779-24), the study is being supported by the U.K. National Institute for Health Research (NIHR) and will be conducted under the coordination of the University of Aberdeen. It is lead by researchers at the University of East Anglia (UEA).
The trial is expected to enroll about 1,576 COPD patients across several sites in the U.K., including at UEA. Eligible patients must have had at least two COPD flare-ups in the past year, and be age 40 or older.
“We have already shown that bisoprolol is safe to use in COPD, in this trial we will assess if bisoprolol might decrease exacerbations of COPD with the ultimate aim to see if it might improve survival,” Brian Lipworth, MD, a professor at the University of Dundee and researcher at the Scottish Centre of Respiratory Disease, said in a news release.
Participants will be randomly assigned to receive oral bisoprolol (at maximum dose of 5 mg a day) or placebo tablets for one year, in addition to standard therapies. To establish the best dose of treatment for each patient, the dose administrated will be slowly increased over four weeks.
During this period, researchers will assess the ability of add-on treatment — with bisoprolol — to lessen the number of COPD-associated pulmonary exacerbations. They will also evaluate the safety and impact of bisoprolol on each patient’s quality of life, pulmonary function, and overall health status.
UEA researchers will also carry out additional analysis to measure the effects of bisoprolol on heart function.
“We are excited to be involved with this important trial,” said Andrew Wilson, MD, a professor and researcher at UEA’s Norwich Medical School. “Beta blocking drugs used to be banned in people with COPD, so it will be interesting to find out whether newer ones reduce flare-up.”
Bisoprolol is a beta-blocker commonly used to manage blood pressure and prevent cardiac problems.
Older versions of beta-blockers were known to have adverse effects on the lungs. But newer agents, such as bisoprolol, are designed with a more specific activity that targets the heart. This has significantly reduced their impact on the lungs, making them safer for patients with pulmonary disorders such as COPD.
Previous studies have shown that treatment with beta-blockers may significantly reduce COPD exacerbations by 27% to 38%, regardless of the presence of cardiac problems.
As bisoprolol is cost-effective, it may represent a new way of easing the risk of COPD flares, and reducing the burden of COPD on the U.K.’s public health system, known as the National Health System (NHS).
“The evidence that beta-blockers might help people with COPD is very exciting and a potential game changer in our approach to this disease,” Graham Devereux, MD, PhD, a researcher at the University of Aberdeen, concluded.