Actively Recruiting
Corticosteroid Tapering in Sarcoidosis
Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2026-03-27
100
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sarcoidosis is an inflammatory disease that commonly affects the lungs but can involve many parts of the body. Its cause is unknown, and while some patients may not need treatment, others require long-term therapy. This research evaluates two different ways to reduce corticosteroid medication, specifically prednisolone, to find the best approach for patients with stable sarcoidosis who are currently taking daily doses between 5mg and 10mg. The study is randomized and aims to understand how many patients can reduce their steroid dose by at least half and to monitor related effects. Participants will be randomly assigned to one of two prednisolone tapering plans: a standard taper or a faster taper. Both plans start by reducing the dose by 2.5mg every four weeks until reaching 5mg per day. Then, the standard taper reduces by 1mg every six weeks until 3mg, while the fast taper reduces by 1mg every two weeks until 3mg. At 3mg, a blood test measuring serum cortisol is done, and if levels are above 25nmol/L, tapering continues at a slower pace. The fast taper group receives phone support every two weeks to assist with the regimen. Some participants will also undergo tests to assess body composition and muscle strength. Throughout the study, participants attend a baseline in-person visit to complete questionnaires about quality of life and fatigue, with follow-up visits mainly conducted by phone when reaching certain dose milestones (5mg and 3mg). Blood tests for cortisol are done two weeks after reaching 3mg. After completing the taper or reaching the lowest dose possible, a final phone visit occurs six weeks later with additional assessments for some participants. One year after randomization, researchers review medical records to check current prednisolone doses. The main outcome measured is the proportion of patients achieving at least 50% reduction in prednisolone dose, along with tracking quality of life, steroid withdrawal symptoms, and body composition changes.
CONDITIONS
Brief Title
Corticosteroid Tapering in Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed sarcoidosis by histological diagnosis and/or multidisciplinary team diagnosis
- Taking prednisolone 5 to 10 mg per day for more than 6 months
- Clinically stable sarcoidosis for more than 6 months with no recent flares or dose increases
- Age 18 years or older
- Able and willing to provide written informed consent
- May be on or off a second-line medication for sarcoidosis
You will not qualify if you...
- Presence of cardiac or neurosarcoidosis
- Advanced lung sarcoidosis defined by composite physiological index over 40 or pulmonary hypertension
- Active sarcoidosis flare or steroid dose increase in the past 6 months
- Known adrenal insufficiency
- Pregnancy or breastfeeding
- Previous or current use of infliximab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and baseline assessments including demographic and clinical data, and lung function testing if not done in the last 6 months.
Duration - Variable duration depending on tapering speed until completion of steroid wean or lowest achievable dose.
Participants are randomized to follow either a standard or fast prednisolone tapering regimen, reducing their steroid dose over time with monitoring and support.
1 baseline in-person visit and multiple phone visits at prednisolone doses of 5mg/day (if applicable), 3mg/day, and 6 weeks after taper completion or lowest dose achieved; serum cortisol measurement 2 weeks after reaching 3mg/day; subset of participants have additional in-person body composition assessments at baseline and final visit.
Duration - 12 months after randomization
Participants’ medical records are reviewed 12 months after randomization to determine current prednisolone dose without requiring patient contact.
No participant visits; medical record review only.
Trial Site Locations
Total: 1 location
1
Royal Brompton Hospital
London, United Kingdom, SW36NP
Actively Recruiting
Research Team
V
Vasileios Kouranos
J
Jessica Raja
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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