CompletedPhase IVInterventional

Can commonly used treatment with inhaled corticosteroids protect COPD patients from heart and blood vessel disease?

Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that makes breathing difficult. People with COPD also face a higher risk of heart and circulatory problems. Researchers believe this may happen because the lining of their blood vessels ages faster than normal. This study explores whether an inhaled steroid can protect blood vessels from this early ageing. Researchers are comparing two common inhalers: one containing two lung-opening medicines, and another containing the same two medicines plus an inhaled steroid (known as 'triple therapy'). Participants will take one of these inhalers for 12 weeks. Researchers will run non-invasive tests and take blood samples to see how well blood vessels are working. The results could help doctors find better ways to protect people with COPD from heart disease.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

Imperial College London

Enrolment target

Start

26 Feb 2025

Estimated completion

05 Mar 2026

Chronic obstructive pulmonary disease (COPD)

What is this study about?

Chronic obstructive pulmonary disease, or COPD, is a common condition that affects the lungs and causes breathing problems. Many people with COPD also develop heart and circulatory issues. Doctors know that the thin layer of cells lining our blood vessels plays a huge role in heart health. In people with COPD, these cells often seem to wear out and age faster than they should, which can lead to stiffer blood vessels and heart trouble.

Doctors often prescribe inhalers that open the airways to treat COPD. Some inhalers also include a steroid, which calms swelling and inflammation in the lungs. Early research suggests that COPD patients who use these steroid inhalers might have healthier, more youthful blood vessel cells than those who do not. However, we need clear evidence to confirm whether these inhalers truly protect the heart.

This trial compares two regular COPD inhaler treatments over 12 weeks. One group will receive an inhaler with two airway-opening drugs, while the other group will receive an inhaler that also adds a steroid. By checking blood vessel health before and after treatment, the research team hopes to learn whether this treatment can keep blood vessels working well and prevent future heart problems.

Key takeaways

Tests whether steroid inhalers can protect blood vessels and the heart in people with COPD.
Compares two standard, approved COPD inhalers over a 12-week period.
Involves two or three visits to the clinic in London for simple, non-invasive health tests and blood samples.
Open to adults with COPD who are not currently using a regular steroid inhaler.
Participation is entirely voluntary and you can stop taking part at any time.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with COPD and are currently troubled by daily symptoms like breathlessness or coughing. To join, you must not already be using a regular steroid inhaler, and your lung function should be moderately reduced, but not very severe.

You cannot take part if your COPD is extremely severe or if you have had serious flare-ups recently that needed hospital care or treatment with steroid tablets or antibiotics in the last six weeks. People with major heart conditions, irregular heartbeats, asthma, severe kidney disease, or other serious long-term illnesses are also unable to join.

In addition, this trial is not suitable for anyone who is pregnant, breastfeeding, allergic to the study medicines or latex, or taking blood-thinning antiplatelet medicines. The study doctor will review your full medical history to make sure taking part is safe for you.

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 an adult aged 18 or older with a confirmed diagnosis of COPD.
I have regular COPD symptoms (such as daily breathlessness or coughing).
I do not currently take a daily steroid inhaler.
I have not had a severe COPD flare-up needing hospital care in the past year.
I do not have a major heart condition, asthma, or an allergy to latex.
I am not currently pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for about 12 weeks and involves two or three visits to the research centre at Imperial College London and Royal Brompton Hospital. During your first visit, the team will review your health, check your inhaler technique, test your lung capacity with a breathing test, and ask you to complete a brief questionnaire about your symptoms.

You will also have your blood pressure checked, complete a simple exercise test, undergo a painless scan using a blood pressure cuff to see how your blood vessels work, and give a blood sample (around four to five tablespoons). If you wish, the initial check and main study tests can be done on the same day in under four hours. You will then collect your study inhaler from the hospital pharmacy to use at home for 12 weeks.

You will be placed into one of two groups to take either a two-drug inhaler or a three-drug inhaler containing a steroid. After 12 weeks, you will return for a final visit to repeat the breathing, blood, and blood vessel tests so researchers can see if there are any changes.

Potential risks and benefits

You may not get any direct health benefit from taking part, but the detailed lung and health checks could provide useful information about your condition, and your participation will help doctors improve future care for people with COPD. The study procedures are generally very safe. Blood tests can cause brief discomfort or slight bruising, and a small number of people may feel faint. The arm cuff used to check blood vessel health can feel tight, but it is completely harmless and can be deflated immediately if it bothers you. Both inhalers are already widely prescribed and well-tolerated NHS treatments. Taking part is completely voluntary, and you are free to leave the study at any time without your regular medical care being affected.

Locations (2)

Royal Brompton Hospital
Approximate
London, England
Imperial College Healthcare NHS Trust
City only
London, England

Common questions

What is the main goal of this study?

The study aims to see if adding an inhaled steroid to standard COPD inhalers helps prevent blood vessels from ageing too quickly and reduces the risk of heart disease.

Are the inhalers being tested new or experimental?

No. Both inhalers (Bevespi and Trixeo) are already approved, commonly prescribed treatments for COPD in the UK.

How much blood will be taken?

The team will take about 80 millilitres of blood, which is around four to five tablespoons, during each testing visit.

Can I leave the study if I change my mind?

Yes. You can withdraw from the study at any point without giving a reason, and it will not affect your normal NHS care in any way.

Do I have to pay for the study medications?

No, all study-related medications, tests, and visits are provided at no cost to you.

How to find out more

Koralia Paschalaki

k.paschalaki@imperial.ac.uk +44 (0)20 7594 2728 Official trial record

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