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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard prednisolone taper
DrugIf initial dose of prednisolone \> 5mg/day then dose will be reduced by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg/day every 6 weeks until 3mg/day. At 3mg/day a serum cortisol will be measured after 2 weeks. If cortisol \> 25nmol/L, then continue with the Meeran prednisolone taper protocol which is reducing by 1mg every 7 days.
Fast prednisolone taper
DrugIf initial prednisolone dose \> 5mg/day then reduce by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg every 2 weeks until 3mg/day. At 3mg/day then measure serum cortisol after 2 weeks. If cortisol \> 25nmol/L then continue to taper by 1mg every 2 weeks. In this arm, patients will contacted over the phone every 2 weeks to provide support with the tapering regimen.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard prednisolone taperActive comparator 1 intervention
Group B: Fast prednisolone taperActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients achieving a prednisolone dose < 50% of baseline dose
To evaluate the proportion of patients achieving a prednisolone dose ≤50% of baseline utilising two tapering regimens (standard vs. fast) while maintaining clinical stability
Time frame
From enrolment to 6 weeks after complete steroid wean or lowest prednisolone dose achievedSecondary outcomes
1
The need for initiation or escalation of non-steroidal immunosuppressive therapy
To evaluate the proportion of patients achieving a prednisolone dose ≤50% of baseline without the need for initiation or escalation of non-steroidal immunosuppressive therapy
Time frame
Enrolment to 6 weeks after either complete steroid wean or lowest achieved prednisolone dose2
Number and length of interruptions to prednisolone taper
Measurement of the number and the length of any interruptions to the prednisolone taper
Time frame
Enrolment until 6 weeks following complete steroid wean or lowest achieved prednisolone dose3
Evaluation of changes in quality of life
Using the King's sarcoidosis questionnaire (KSQ) to determine any changes in quality of life with prednisolone tapering This questionnaire will be performed at: 1. Baseline visit 2. 5mg/day visit (when participant reaches 5mg/day of prednisolone (only if baseline prednisolone dose \> 5mg/day) and the exact time this will occur will vary depending on whether participant in the standard or fast taper arm) 3. 3mg/day visit (when participant reaches 3mg/day of prednisolone and the exact time this will occur will vary depending on whether participant is in the standard or fast taper arm) 4. Final visit (this will occur 6 weeks after complete wean of steroid or lowest achievable prednisolone dose) There are 5 domains (general health status, lung, skin, eyes and medications) each domain is scored between a range between 0-100. 0 indicates the lowest or worst health status and 100 indicates the best health/highest quality of life.
Time frame
See in description as insufficient space for the detail above to be entered in this section4
Proportion of patients with cortisol levels < 25nmol/L at prednisolone dose 3mg/day
2 weeks following reaching prednisolone dose of 3mg/day, morning blood cortisol level will be taken
Time frame
This will be performed 2 weeks after reaching prednisolone dose of 3mg/daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov