Corticosteroid Tapering in Sarcoidosis

Recruiting now · Not applicable

Conditions studied: Sarcoidosis

In brief

Sarcoidosis is an inflammatory condition affecting many different parts of the body but most commonly the lungs. It is not known what causes sarcoidosis. In some patients no treatment is needed but in other patients long term treatment may be required. One of the main medications used to manage this condition is corticosteroids. This medication has been shown to be very effective at reducing inflammation in this condition and many patients often remain on it for months to years. Unfortunately, there are many negative long-term side effects of corticosteroid use. This includes an increased risk of developing diabetes, reduced bone density, weight gain, high blood pressure and low muscle mass. Currently there are no guidelines for how steroids should be weaned in patients who have stable sarcoidosis. The investigators aim to undertake a study at the Royal Brompton Hospital which will be assessing two different steroid tapering regimens which will be allocated to participants in a randomised manner. This will be the first study to directly evaluate different steroid weaning regimens in sarcoidosis patients. The main aim of this study is to determine how many participants can reduce their prednisolone dose to less than 50% from their baseline dose. Additionally, the investigators will be recording how many participants require an increase in dose or an additional medication whilst on the prednisolone weaning regimen. The investigators will also see the tolerability of steroid withdrawal and assess for any symptoms of steroid withdrawal. In a small subset of participants the investigators will assess for any changes in body composition and muscle strength using bioelectrical impedance analysis and isometric muscle testing.

Key facts

Study ID

NCT07498842

Run by

Royal Brompton & Harefield NHS Foundation Trust

People needed

100

Starts

2026-03-19

Expected to finish

2027-10-18

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed sarcoidosis by: (a) Histological diagnosis and/or (b) Multidisciplinary Team (MDT) diagnosis
• Prednisolone 5-10mg/day for > 6 months
• Clinically stable disease for > 6 months (no flares or dose escalation)
• On or off second-line agent
• > 18 years old
• Written informed consent provided

You may not qualify if…

• Cardiac or neurosarcoidosis
• Advanced pulmonary sarcoidosis defined as either: (a) composite physiological index (CPI) > 40 (b) pulmonary hypertension
• Active sarcoidosis flare or dose escalation in the past 6 months
• Known adrenal insufficiency
• Pregnancy or breastfeeding
• Previous or current infliximab use

Where it is running

• Royal Brompton Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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