Corticosteroid Tapering in Sarcoidosis

This study will be assessing prednisolone tapering in patients with sarcoidosis. The investigators will be recruiting patients with stable sarcoidosis who are currently on a prednisolone dose between 5mg-10mg/day. The study aims to determine if participants are able to reduce their prednisolone dose to at least 50% of their initial baseline dose when entering the trial.

The two tapering regimens are as follows:

Standard taper: If prednisolone \> 5mg/day then reduce by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5 mg/day to reduce by 1mg/day every 6 weeks until 3mg/day. At 3 mg/day: measure serum cortisol. If cortisol \> 25nmol/L, then continue with Meeran prednisolone taper protocol which is reducing by 1mg every 7 days.

Fast taper: If prednisolone \> 5mg/day then reduce by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5 mg/day: reduce by 1 mg every 2 weeks until 3 mg /day. At 3 mg/day then measure serum cortisol: If cortisol \> 25nmol/L, continue taper by 1 mg every 2 weeks. In this fast taper participants will be contacted over the phone every 2 weeks to provide support with the tapering regimen.

Participants who meet both the inclusion and exclusion criteria will be screened. Informed consent will then be performed and the following demographic and clinical characteristics will be collected (age, sex, smoking history, ethnicity, co-morbidities, medications and baseline lung function data (FEV1% predicted, FVC% predicted, DLCO% predicted). If lung function testing has not been performed in the previous 6 months this will be arranged. A dedicated lung function slot has been allocated once every week to facilitate this as agreed upon with the head of the lung function department.

Participants will then be randomised to either the standard or the fast prednisolone tapering regimen by computer-generated sequence using random block design with stratification by background steroid sparing agents.

After randomisation, a baseline visit will occur this will be an in person visit at the Royal Brompton Hospital. At the baseline visit the following questionnaires will be performed kings sarcoidosis questionnaire (KSQ), fatigue assessment score (FAS), patient global assessment (PGA) and addison's disease (AD) quality of life questionnaire (AddiQoL).

In a subset of participants (30 patients, 15 per arm) further testing on body composition will be performed and includes bioelectrical impedance analysis, 5 times sit to stand testing and isometric quadriceps testing (these tests will all be performed at the Royal Brompton Hospital).

The next visit which will be performed as a phone visit will be once participants reach a prednisolone dose of 5mg/day (this visit will not occur in any participants who have a starting baseline prednisolone dose of 5mg). At this visit the following questionnaires will be performed kings sarcoidosis questionnaire (KSQ), fatigue assessment score (FAS), patient global assessment (PGA) and addison's disease (AD) quality of life questionnaire (AddiQoL).

The next visit will be performed as a phone visit once participants reach a prednisolone dose of 3mg/day. At this visit the following questionnaires will be performed kings sarcoidosis questionnaire (KSQ), fatigue assessment score (FAS), patient global assessment (PGA) and addison's disease (AD) quality of life questionnaire (AddiQoL).

Additionally, all participants 2 weeks after reaching prednisolone 3mg/day will have a serum cortisol measurement taken. This test is performed as part of routine clinical practice and will be performed at the pathology department at the Royal Brompton Hospital.

The final visit will be performed as a phone visit 6 weeks after participants have completed the tapering regimen or have reached the lowest achievable prednisolone dose. At this final visit the following questionnaires will be performed; kings sarcoidosis questionnaire (KSQ), fatigue assessment score (FAS), patient global assessment (PGA) and addison's disease (AD) quality of life questionnaire (AddiQoL).

Additionally in the same subset of patients who underwent body composition assessment at the baseline visit bioelectrical impedance analysis, 5 times sit to stand testing and isometric quadriceps testing (these tests will all be performed at the Royal Brompton Hospital).

After 12 months following randomisation, participants medical records will be reviewed to determine current prednisolone dose. No patient contact is required at this stage.

• The need for initiation or escalation of non-steroidal immunosuppressive therapy [Срок оценки: Enrolment to 6 weeks after either complete steroid wean or lowest achieved prednisolone dose]
• Number and length of interruptions to prednisolone taper [Срок оценки: Enrolment until 6 weeks following complete steroid wean or lowest achieved prednisolone dose]
• Evaluation of changes in quality of life [Срок оценки: See in description as insufficient space for the detail above to be entered in this section]
• Proportion of patients with cortisol levels < 25nmol/L at prednisolone dose 3mg/day [Срок оценки: This will be performed 2 weeks after reaching prednisolone dose of 3mg/day]
• Assess for symptoms of steroid withdrawal, safety and tolerability with prednisolone weaning [Срок оценки: See in description as insufficient space for the detail above to be entered in this section]
• Evaluation of prednisolone dose [Срок оценки: See in description as insufficient space for the detail above to be entered in this section]
• Changes in body composition measured with bioimpedance analysis (BIA) [Срок оценки: BIA will be performed at the baseline visit and final visit (6 weeks following complete steroid wean or lowest achieved steroid dose).]
• Change in body composition using isometric quadriceps testing strength [Срок оценки: This will be performed at baseline and final visit (6 weeks following complete prednisolone wean or lowest achieved prednisolone dose).]
• Changes in body composition using 5 times sit to stand test (5STS) [Срок оценки: 5STS will be performed at baseline and final visit (6 weeks following complete steroid wean or lowest achieved steroid dose).]
• Evaluation of changes in quality of life and fatigue [Срок оценки: See in description as insufficient space for the detail above to be entered in this section]
• Changes in body composition measured with bioimpedance analysis (BIA) [Срок оценки: This testing will be performed at the baseline visit and final visit (6 weeks following complete steroid wean or lowest achieved steroid dose).]
• Changes in body composition measured with bioimpedance analysis (BIA) [Срок оценки: This measurement will be performed at the baseline visit and final visit (6 weeks following complete steroid wean or lowest achieved steroid dose).]