RecruitingPhase IIIInterventional

Testing oral corticosteroids versus placebo for the treatment of fibrotic hypersensitivity pneumonitis

This study, called CHORUS, investigates whether steroids (prednisolone) can help people with fibrotic hypersensitivity pneumonitis (FHP). FHP is a severe lung condition where the lungs become scarred, making it hard to breathe. About 2,000 new cases occur yearly in the UK, often affecting those over 65. Currently, treatments vary widely, and there's no standard approach. Participants will be randomly given either steroid tablets or dummy tablets for six months. Researchers will measure lung function, symptoms like breathlessness and cough, and quality of life to see if steroids are beneficial. The goal is to find better treatment guidelines for FHP patients and improve their care.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Exeter

Enrolment target

222

Start

01 May 2025

Estimated completion

31 Mar 2027

Fibrotic hypersensitivity pneumonitis

What is this study about?

Fibrotic hypersensitivity pneumonitis (FHP) is a serious and life-changing lung condition that causes scarring in your lungs. This scarring makes it harder and harder to breathe, leading to a harsh cough, weight loss, and a significant drop in your quality of life. For many, it can lead to becoming housebound, and on average, people live for about five years after diagnosis. While it's relatively rare, affecting about 3 in every 100,000 people, it's more common in those over 65, affecting about 11 in 100,000.

FHP is particularly tricky because it involves both swelling (inflammation) and scarring (fibrosis) in the lungs. There's currently no single, widely agreed-upon way to treat it, and care can differ significantly depending on where you live. This study aims to find out if a common type of steroid drug, called prednisolone, can help people with FHP. Doctors already use steroids for FHP, but this study will provide clear evidence on how effective they truly are.

By taking part, you could contribute valuable information that will help doctors across the UK and beyond better understand and treat FHP in the future. The results will help guide decisions on which treatments are most beneficial for FHP patients, potentially improving quality of life and outcomes for many.

Key takeaways

Tests if steroids (prednisolone) help fibrotic hypersensitivity pneumonitis (FHP).
FHP is a serious lung scarring condition affecting breathing.
Participants take either steroids or dummy pills for 6 months.
Compares lung function and quality of life between groups.
Study aims to improve future FHP treatment guidelines.
Run by the University of Exeter and funded by the Health Technology Assessment Programme.

Who may be eligible?

To join this study, you need to be aged 18 or older. You must have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP) within the last six months by a team of lung specialists. Your lung function tests need to meet certain levels, and a CT scan of your lungs should show more than 10% scarring.

There are also some reasons why you couldn't join. For example, if you've already been treated with steroids or other immune-suppressing drugs for FHP, or if you have an active infection. You also couldn't participate if you have certain other serious health problems, such as poorly controlled diabetes, advanced kidney or liver disease, or unstable heart conditions. Being very overweight (BMI over 44) would also exclude you.

It's also important that you're not currently taking part in another drug trial. If you are able to have children, you would need to agree to use effective contraception during the study and let the study team know if you become pregnant.

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?
Have you been diagnosed with FHP by specialists in the last 6 months?
Is your FHP diagnosis confirmed by a CT scan showing lung scarring?
Are you able to provide your full consent to participate?
Do you have any serious health conditions that might make taking steroids risky?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive steroid tablets (prednisolone), and the other will receive dummy tablets (placebo). Both types of tablets will look exactly the same.

You'll take these tablets for six months. During this time, you'll have regular check-ups, which will include standard lung function tests at the start, and again after three and six months. You'll also be asked to fill out questionnaires about your symptoms, such as how breathless you are, any cough you have, and your general quality of life. The research team will carefully monitor you for any potential side effects from the medication. You'll continue to take any other regular medications you have for other health conditions as usual. The entire study will last for six months of treatment, with follow-up appointments after that to track your health.

Potential risks and benefits

Taking part in this study could potentially help shape future treatments for FHP, benefiting many people with this condition. However, steroids like prednisolone can have side effects, and some may be more likely if you're taking the active drug. The study team will discuss all potential side effects with you before you agree to take part, and will monitor you closely throughout the study. Since some people will receive a dummy tablet, there's a chance your condition might not improve or could worsen without active treatment, but we don't know if this risk is any different than for those on the steroid. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (18)

Royal Devon University Healthcare NHS Foundation Trust
City only
Exeter, England
Royal Brompton Hospital
Approximate
London, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
City only
Norwich, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
North Bristol NHS Trust
City only
Bristol, England
NHS Tayside
City only
Dundee, Scotland
University Hospitals of Leicester NHS Trust
City only
Leicester, England
University Hospitals of Morecambe Bay NHS Foundation Trust
City only
Kendal, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
University College London Hospitals NHS Foundation Trust
City only
London, England
Guys & St Thomas Foundation Trust
Unverified
London, England
Wythenshawe Hospital
Unverified
Manchester, England

Common questions

What is FHP?

FHP (fibrotic hypersensitivity pneumonitis) is a serious lung disease that causes scarring and makes it hard to breathe.

What are steroids?

Steroids are medicines, like prednisolone, that can reduce swelling and inflammation in the body.

Will I know if I'm getting steroids or a dummy pill?

No, neither you nor your doctor will know whether you are receiving the steroid or the dummy pill until the study ends. This is to ensure fair results.

How long will I take part?

You will take the study medication for six months, with follow-up check-ups during that time.

Can I stop taking part if I want to?

Yes, you can choose to leave the study at any time, and it will not affect your usual medical care.

How to find out more

Lucy Tregellas

l.fleming2@exeter.ac.uk 07507881768 Official trial record

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