RecruitingPhase IVInterventional

Testing if the BCG vaccine alters exacerbations in people with chronic obstructive pulmonary disease

Researchers are investigating whether the BCG vaccine, often given for tuberculosis, can help people with a lung condition called COPD. This vaccine might strengthen the immune system, making it better at fighting off common infections that lead to flare-ups (exacerbations) in COPD. These flare-ups can worsen lung health and quality of life. The study aims to compare how many flare-ups occur over a year in people with COPD who receive the vaccine versus those who don't. It will also look at symptoms, quality of life, and hospital visits. The goal is to find new ways to prevent chest infections and improve the long-term health of people living with COPD.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University of Birmingham

Enrolment target

804

Start

21 Oct 2025

Estimated completion

30 Nov 2026

Chronic obstructive pulmonary disease (COPD)

What is this study about?

You might know the BCG vaccine as a protection against tuberculosis. However, recent small studies have hinted that it might offer other benefits, potentially by boosting the body's natural defences (immune system) against various infections. This could be particularly helpful for older people, possibly even reducing hospital admissions.

Flare-ups, also called exacerbations, are very common in people with chronic obstructive pulmonary disease (COPD). These flare-ups are often caused by infections and can make your lung condition worse, significantly impacting your daily life. Preventing these frequent infections is crucial for maintaining your lung health and overall well-being. This study wants to see if the BCG vaccine can help break this cycle of repeated infections and improve lung health over time.

The main aim of this study is to test if the BCG vaccine can reduce the number of these chest infection flare-ups in people with COPD. Researchers will also be looking closely at how people's symptoms change, their general quality of life, and if there's any difference in hospital visits between those who get the vaccine and those who don't. They'll also collect some samples to understand how the vaccine might be changing the immune system.

Key takeaways

Exploring if the BCG vaccine can reduce chest infections in COPD.
Participation involves a one-year follow-up.
Aims to improve quality of life and reduce hospital visits for COPD.
You might receive the vaccine or be in a control group.
Potential for mild, common vaccine side effects.
Your involvement helps advance COPD research.

Who may be eligible?

The study is looking for adults aged 18 or over who have been diagnosed with COPD. To take part, you would need to have experienced at least two flare-ups (exacerbations) of your COPD within the last 12 months.

There are certain reasons why you might not be able to join. For example, if you are pregnant, have a weakened immune system, or have had certain types of allergic reactions to vaccines in the past. If you've recently taken high doses of a steroid medication called prednisolone for more than two weeks, you might also not be able to participate. Your doctor will carefully check all these points to see if the study is right for you.

Ultimately, your study doctor will decide if you are suitable to join based on your health and medical history, ensuring your safety throughout the trial.

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.

Are you 18 years old or older?
Do you have a diagnosis of COPD?
Have you had at least two COPD flare-ups in the last year?
Are you currently pregnant or planning to be during the study?
Have you been told you have a weakened immune system?
Have you had a severe allergic reaction to a vaccine before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups: one group will receive the BCG vaccine, and the other group will not. The study involves following you closely for one year after this.

During this year, researchers will ask you about your symptoms, how your quality of life is, and keep track of any hospital admissions. They will also take some blood tests at the beginning of the study and again after one year to see how your immune system is working. If you experience a flare-up of your COPD during the study, you'll be asked to send a sample from home, which will help researchers look for viruses and bacteria that might be causing it. All necessary materials for collecting and sending samples will be provided, aiming to make it as easy as possible for you.

Potential risks and benefits

The main benefit of taking part in this study could be helping us find new ways to prevent chest infections and improve the long-term health of people with COPD. While it's not guaranteed that you personally will benefit, your involvement will contribute vital information to medical understanding. The BCG vaccine has been used for many years, and most side effects are generally mild, such as feeling tired, headaches, or muscle aches, similar to other vaccines. Rarely, more serious allergic reactions can occur, but these are very uncommon, and the vaccine will be given in a medical setting where staff are prepared to handle them. There's also a very small risk of getting a specific type of infection if your immune system is unknowingly weakened, which is why strict checks are in place to exclude people with known immune problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
United Kingdom

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, usually due to long-term exposure to harmful gases or particles, most often from smoking.

What are 'exacerbations'?

Exacerbations are sudden worsenings or flare-ups of your COPD symptoms, often caused by infections. They can make you feel much worse and sometimes require hospital treatment.

What is the BCG vaccine?

The BCG vaccine is a vaccine primarily used to protect against tuberculosis (TB). This study is exploring if it has other benefits for people with COPD.

Will I or my doctor know if I received the vaccine?

No, because it's a 'blinded' study, neither you nor your doctor will know whether you received the vaccine or not. This helps ensure fair results.

How long will the study last for me?

If you join the study, you would be followed for one year after receiving the vaccine or not.

How to find out more

Alice Turner

a.m.turner@bham.ac.uk - Official trial record

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