CompletedNot ApplicableInterventional

Bisoprolol in COPD study

Chronic Obstructive Pulmonary Disease (COPD) causes breathing difficulties and sudden chest flare-ups that can lead to hospital stays. Bisoprolol is a common, low-cost medicine called a beta-blocker, usually prescribed for heart conditions and high blood pressure. In the past, doctors avoided giving beta-blockers to people with lung conditions due to concerns they might narrow the airways. However, modern beta-blockers like bisoprolol mainly target the heart and appear safe for people with lung problems. This study aims to discover whether adding bisoprolol to standard COPD treatments helps prevent flare-ups and eases breathlessness. Participants take either bisoprolol or a dummy pill (placebo) once daily for one year. By comparing the two groups, researchers hope to see if this inexpensive medication can improve daily life for people with COPD and reduce the strain on NHS hospitals.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Aberdeen

Enrolment target

1,574

Start

01 Sep 2018

Estimated completion

31 May 2022

Chronic obstructive pulmonary disease (COPD)

What is this study about?

Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung condition that makes it hard to breathe. In the UK, more than one million people live with COPD. Many experience sudden worsening of their symptoms, often called flare-ups or exacerbations. These flare-ups can be frightening, frequently require antibiotics or steroids, and are a leading reason people with COPD need hospital care.

Bisoprolol belongs to a group of medicines known as beta-blockers. For many years, doctors hesitated to prescribe beta-blockers to people with COPD because older types could trigger airway tightness. Newer beta-blockers like bisoprolol work far more selectively on the heart, and recent research suggests they are not only safe for people with lung conditions but might also cut down the number of chest flare-ups they experience.

This trial is testing whether taking bisoprolol every day can safely reduce flare-ups and improve general wellbeing compared to standard care alone. Because bisoprolol is widely available and costs only pennies a day, finding out if it works could lead to an affordable, effective new way to manage COPD across the NHS.

Key takeaways

The study tests whether the heart tablet bisoprolol reduces COPD flare-ups.
Participants take either bisoprolol or a dummy pill once daily for one year.
You continue taking all your regular inhalers and COPD treatments as normal.
Open to adults aged 40 and older who have had at least two flare-ups in the past year.
Taking part is voluntary, and you can stop at any time without affecting your NHS care.

Who may be eligible?

You may be able to join this study if you are 40 years of age or older and have a confirmed diagnosis of COPD from your doctor. Because COPD is strongly linked to smoking, participants also need to have a history of smoking (equivalent to roughly one pack a day for ten years). You should have had at least two flare-ups in the previous year that required treatment with antibiotics or steroid tablets.

To ensure your safety, your chest must be stable when you join, meaning you have not had a flare-up in the past four weeks. You must also be able to swallow tablets and perform simple breathing tests (spirometry). People who also have asthma alongside COPD may still be eligible to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 40 or over.
I have been diagnosed with COPD by a doctor.
I have a smoking history (roughly equal to one pack a day for 10 years).
I have needed antibiotics or steroid tablets for chest flare-ups at least twice in the past year.
My chest has been stable with no flare-ups for at least the last four weeks.
I am able to swallow tablets.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for about 12 months. You will be placed by chance (randomly) into one of two groups: one group takes bisoprolol tablets once a day, and the other group takes an identical dummy tablet (placebo). Neither you nor your study doctor will know which tablet you receive. Over the first four weeks, your dose will be slowly increased to find the right level for you, up to a maximum of 5mg daily. You will continue taking your normal inhalers and COPD medicines throughout.

You will attend study visits at the start, at six months, and at 12 months. During these visits, researchers will check your breathing, review any flare-ups or side effects, carry out blood tests, and ask you to fill in questionnaires about your daily activities, breathlessness, and quality of life.

Potential risks and benefits

Taking part may not help your health directly, but the results could help doctors provide better care for people with COPD in the future. Bisoprolol is generally well-tolerated, but like all medicines, it can cause side effects such as tiredness, dizziness, or a slower heart rate. Having blood tests may cause brief stinging or mild bruising. Your health will be closely monitored throughout the study, and you are free to stop taking part at any time without your regular NHS care being affected.

Locations (29)

Aberdeen Royal Infirmary (lead site)
City only
Aberdeen, Scotland
Arrowe Park Hospital
Approximate
Wirral, England
University Hospital of North Tees
City only
Stockton on Tees, England
Blackpool Victoria Hospital
Approximate
Blackpool, England
Royal Lancaster Infirmary
Approximate
Lancaster, England
Royal Infirmary of Edinburgh
Unverified
Edinburgh, Scotland
Norfolk and Norwich University Hospital
Unverified
Norwich, England
Freeman Hospital
Unverified
Newcastle upon Tyne, England
Musgrove Park Hospital
Unverified
Taunton, England
Royal Devon & Exeter Hospital
Unverified
Exeter, England
Derriford Hospital
Unverified
Plymouth, England
South Tyneside District Hospital
Unverified
South Shields, England

Common questions

What is a placebo?

A placebo is a dummy tablet that looks and tastes exactly like the real medicine but contains no active ingredients. It helps researchers fairly test whether any improvements are truly due to the drug.

Will I have to stop taking my usual COPD inhalers?

No. You will continue to take all your standard COPD medicines and inhalers just as you normally do.

Can I leave the study if I feel it is not right for me?

Yes. Participation is entirely voluntary. You can withdraw at any point, and your normal medical care will continue as usual.

Does it cost anything to take part?

No. The study medication and all trial-related appointments and tests are completely free.

Why test a heart medicine for a lung condition?

The heart and lungs work closely together. Modern beta-blockers like bisoprolol appear to protect both organs and early evidence suggests they may reduce lung inflammation and chest flare-ups.

How to find out more

Graham Devereux

g.devereux@abdn.ac.uk +44 (0)151 702 9551/(0)1224 438178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.