What next?
What next?
About this study
Fibrotic Hypersensitivity Pneumonitis (FHP) is a rare lung condition caused by long-term exposure to things like mould, birds, or other allergens in the environment. It leads to lung scarring, making it harder to breathe. It can be life-limiting and currently has no approved treatment.
Steroid tablets like prednisolone are commonly prescribed for lots of conditions to try to reduce inflammation. Doctors often use it to reduce inflammation in the lungs, but we don’t know if this helps. This study, called CHORUS, will test whether prednisolone helps slow down lung damage in people recently diagnosed with FHP.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
This is a Phase 3 clinical trial, which means it’s designed to test how well the treatment works. People who take part will be randomly given either:
- Prednisolone (a steroid used to reduce inflammation), or
- A placebo (a tablet with no active drug ingredients, often referred to as a dummy medication)
You won’t know which one you are getting. The treatment lasts 26 weeks, followed by a 9-week period where the tablets are gradually reduced (to stop side effects).
You’ll have check-ups during the study, including 3 telephone appointments (baseline, week 12 and week 26) and 3 hospital visits (week 4, week 8 & week 35). During the hospital visits, you will have lung function tests (breathing tests), blood tests, and other tests such as blood pressure, oxygen saturation levels, height and weight. You will also be asked to complete questionnaires about how you’re feeling.
You will be offered a small payment at each hospital visit to assist with any travel expenses or car parking charges.
Summary of involvement
26 weeks of treatment with either prednisolone or a placebo
Further 9 weeks to reduce the medication dose
Hospital visits
Telephone appointments
Lung function tests
Blood tests
Other medical tests
Questionnaires
Can I take part?
You may be able to take part if you have been diagnosed with FHP in the last 6 months and are over the age of 18 years.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see the main criteria list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
You are aged 18 years or over
You have a diagnosis of FHP within the last 6 months
If you are of child-bearing potential, you must be willing to take a pregnancy test (if appropriate) and use highly effect methods of contraception
You have had previous treatment of prednisolone or immunosuppresive therapy for FHP
You have an active infection at the start of the study
Your body mass index (BMI) is more than 44 kg/m2
You are currently taking part in another research study for another drug
You have another disease which is currently unstable or significant that the research team may feel makes you unsuitable
What difference could taking part make?
By taking part in this study, you could help answer key questions about the use of steroid tablets for people with FHP. Currently, doctors often prescribe steroids like prednisolone, but there’s no solid proof they work well, and they can often cause side effects. This study could help improve care and create treatment guidelines for people with FHP in the future.
Taking part might not help you personally, but:
- You’ll be closely monitored by specialists throughout the trial.
- You’ll help researchers understand more about this common treatment.
- Your involvement could help improve treatment guidelines for future FHP patients.
- You’ll be contributing to vital research supported by patients, doctors, and charities like Action for Pulmonary Fibrosis.
In short, you can play a key role in shaping how FHP is treated in the future—turning uncertain treatment into evidence-based care.
Where does the study take place?
Study locations
Exeter
Hull
Leicester
Tayside
How to take part
If you’ve recently been diagnosed with FHP and want to find out more, talk to your lung doctor (respiratory specialist). They can tell you if your local hospital is involved in the study.
You can also contact the CHORUS trial team at: chorus@exeter.ac.uk
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
chorus@exeter.ac.ukThis study is supported by
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org