CHORUS
Research type
Research Study
Full title
CHORUS: A multi-centre double-blind randomised placebo-controlled group-sequential superiority trial to assess the effectiveness and cost-effectiveness of oral Corticosteroids in patients witH fibrOtic hypeRsensitivity pneUmonitiS
IRAS ID
1010739
Contact name
Michael Gibbons
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS foundation Trust
ISRCTN Number
ISRCTN58111563
Research summary
Fibrotic hypersensitivity pneumonitis (FHP) is a devastating lung disease which results in scarring of the lungs. As the scarring worsens, patients struggle to breathe. They can develop a harsh, hacking cough, lose a lot of weight, have a deteriorating quality of life and may become housebound. Life expectancy after diagnosis is only 5 years on average. FHP is estimated to affect 3 people per 100,000 but it is more common in those over 65 years (~11 people per 100,000); there are around 2000 new cases per year in the UK.
FHP is unusual because the lungs have both thickening (inflammation) and scarring (fibrosis). This combination makes FHP much more complicated to treat. Treatments and care for people with FHP vary widely across the UK and the world. To determine whether steroids (prednisolone) are beneficial for people with FHP, we will recruit 222 recently diagnosed FHP patients from up to 30 hospitals in England, Scotland, and Wales. Participants will be allocated at random (like tossing a coin) to receive either oral steroid tablets or placebo tablets (which look identical). They will take the steroids or placebo for 6 months. We will prescribe the steroid doses that doctors regularly use, and all participants will continue with any treatments they are taking for other reasons (such as blood pressure medication). The potential benefit of the steroids will be measured using lung function tests at the start, and after 3 and 6 months of treatment. These are reliable tests used in day-to-day clinical care. We will ask participants to fill out questionnaires about their symptoms: breathlessness; cough; and quality of life. We will monitor for any side effects of steroids. We will also investigate whether steroids offer value for money to the NHS and wider care services. The study will provide much-needed evidence for guiding treatment and improving clinical care for FHP patients.REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0018
Date of REC Opinion
27 Feb 2025
REC opinion
Further Information Favourable Opinion