ActiveLungs & BreathingNIHR-supported projectDigestion, Kidneys & Other Organs
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
Recipient organisationNIHR Southampton Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — May 2028
In plain English
AI plain-English summary
A lung disease that scars the lungs and kills most patients within five years has no proven treatment—this trial tests whether cheap steroid pills can change that. Fibrotic hypersensitivity pneumonitis (FHP) affects around 2,000 new patients per year in the UK, mostly over 65. Unlike other lung diseases, FHP combines both inflammation and scarring, making it unclear whether anti-inflammatory steroids help or harm. Current treatment varies wildly across the NHS, with no robust evidence to guide doctors. The trial will recruit 222 recently diagnosed patients from up to 30 UK hospitals. Half will receive oral prednisolone for six months; half will get identical placebo tablets. Researchers will measure lung function at three and six months, track symptoms like breathlessness and cough through questionnaires, and monitor side effects. A health-economic analysis will assess value for money to the NHS. If steroids prove effective, this cheap, widely available drug could become the standard first-line treatment for FHP, halting lung decline and extending life. If they prove ineffective or harmful, the trial will stop doctors from prescribing a treatment that wastes resources and risks side effects. Either way, the study provides the first definitive evidence for managing this neglected disease.
View original technical description
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.
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