Corticosteroid Tapering in Sarcoidosis

ConditionSarcoidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard prednisolone taper
  • Fast prednisolone taper

Treatment groups

100 Participants
are divided into 2 treatment groups