Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07498842

Corticosteroid Tapering in Sarcoidosis

Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2026-03-27

100

Participants Needed

1

Research Sites

82 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Corticosteroid Tapering in Sarcoidosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Royal Brompton Hospital

London, United Kingdom, SW36NP

Actively Recruiting

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Research Team

V

Vasileios Kouranos

CONTACT

J

Jessica Raja

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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