SarcoidosisSARC-TaperNCT07498842
Corticosteroid Tapering in Sarcoidosis
A study testing Standard prednisolone taper and Fast prednisolone taper in people with Sarcoidosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Standard prednisolone taper and Fast prednisolone taper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2026to 18 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Raja contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, SW36NP
Vasileios Kouranos, 020 7352 8121, vasileios.kouranos@nhs.net
Vasileios Kouranos
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Sarcoidosis
- Being tested
- Standard prednisolone taper, Fast prednisolone taper
- Keywords
- corticosteroid tapering
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard prednisolone taperDrug
If 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 taperDrug
If 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard prednisolone taper | Active comparator | If 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. Receives: Drug: Standard prednisolone taper |
| Fast prednisolone taper | Active comparator | If 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. Receives: Drug: Fast prednisolone taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrolment to 6 weeks after complete steroid wean or lowest prednisolone dose achieved
Secondary outcomes (13)
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
Measured: Enrolment to 6 weeks after either complete steroid wean or lowest achieved prednisolone dose
Number and length of interruptions to prednisolone taper
Measurement of the number and the length of any interruptions to the prednisolone taper
Measured: Enrolment until 6 weeks following complete steroid wean or lowest achieved prednisolone dose
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:
- Baseline visit
- 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)
- 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)
- 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.
Measured: 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
2 weeks following reaching prednisolone dose of 3mg/day, morning blood cortisol level will be taken
Measured: 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
Using Addison's Disease (AD) quality of life questionnaire (AddiQoL) to determine if any symptoms of steroid withdrawal
This questionnaire will be performed at:
- Baseline visit
- 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)
- 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)
- Final visit (this will occur 6 weeks after complete wean of steroid or lowest achievable prednisolone dose)
The final total score is calculated as the algebraic sum of all item scores, with a maximum possible score of 120 points, a higher total score indicates a better overall quality of life (there are no specific cut-off scores).
Measured: See in description as insufficient space for the detail above to be entered in this section
Evaluation of prednisolone dose
Prednisolone dose will be recorded at:
- Final visit (this is defined as 6 weeks post complete steroid wean or lowest achievable steroid dose, due to 2 different steroid tapering regimens this will vary between participants)
- 12 months post randomisation (randomisation occurs at baseline visit in all patients) (this is not a study visit but participants will be consented for medical notes to be accessed at this time point)
Measured: 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)
In a subset of 30 patients (15 in each arm) we will performing bioimpedance analysis to determine any changes in body composition. We will recording phase angle (PhA) which is measured in units ° (degrees) and is a calculated value provided by the bioimpedance machine.
Measured: 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
In a subset of 30 patients (15 in each arm) we will be performing isometric quadriceps testing.
Measured: 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)
This test will be performed in a subset of 30 patients (15 in each arm). The 5STS is a functional test assessing quadricep strength.
Measured: 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
Using the fatigue assessment scale (FAS) to determine any changes in quality of life with prednisolone tapering
This questionnaire will be performed at:
- Baseline visit
- 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)*
- 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)
- Final visit (this will occur 6 weeks after complete wean of steroid or lowest achievable prednisolone dose)
Fatigue assessment scale is score range 10-50. Less than 22 indicates normal levels of fatigue, 22-34 indicates mild to moderate fatigue, greater than 35 indicates severe fatigue
Measured: 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)
In a subset of 30 patients (15 in each arm) we will performing bioimpedance analysis to determine any changes in body composition. We will recording skeletal muscle mass (SMM) which is measured in kg.
Measured: 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)
In a subset of 30 patients (15 in each arm) we will performing bioimpedance analysis to determine any changes in body composition. We will recording phase fat free muscle index (FFMI) which is calculated by the bioimpedance machine by the measurement of fat free mass (measured in kg) divided by height in m^2. (FFM(kg)/m^2 = fat free mass index (FFMI).
Measured: This measurement 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)
In a subset of 30 patients (15 in each arm) we will performing bioimpedance analysis to determine any changes in body composition. We will recording appendicular skeletal muscle mass (ASMM) which is measured in kg.
Measured: This measurement will be performed at the baseline visit and final visit (6 weeks following complete steroid wean or lowest achieved steroid dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start19 Mar 2026
- Primary completion28 Jun 2027 (estimated)
- Study completion18 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vasileios Kouranos, Principal investigator, Interstitial Lung Disease Department, Royal Brompton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498842
- Sponsor's protocol ID
- IRAS ID: 367551
- Acronym
- SARC-Taper
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Tapering in Sarcoidosis
- ClinicalTrials.gov ID
- NCT07498842
- Acronym / sponsor ID
- SARC-Taper / IRAS ID: 367551
- Conditions
- Sarcoidosis
- Keywords
- corticosteroid tapering
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 18 Oct 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard prednisolone taper | Active comparator | Drug: Standard prednisolone taperIf 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 | Active comparator | Drug: Fast prednisolone taperIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard prednisolone taperIf 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. | Drug | Standard prednisolone taper |
| Fast prednisolone taperIf 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. | Drug | Fast prednisolone taper |
Primary outcome
Proportion of patients achieving a prednisolone dose < 50% of baseline dose
Time frame: From enrolment to 6 weeks after complete steroid wean or lowest prednisolone dose achieved
To evaluate the proportion of patients achieving a prednisolone dose ≤50% of baseline utilising two tapering regimens (standard vs. fast) while maintaining clinical stability
13 secondary outcomes
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 dose
Number and length of interruptions to prednisolone taper
Time frame: Enrolment until 6 weeks following complete steroid wean or lowest achieved prednisolone dose
Evaluation of changes in quality of life
Time frame: 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
Time frame: 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
Time frame: See in description as insufficient space for the detail above to be entered in this section
Evaluation of prednisolone dose
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: This measurement 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)
Time frame: This measurement will be performed at the baseline visit and final visit (6 weeks following complete steroid wean or lowest achieved steroid dose).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Raja contact
Vasileios Kouranos principal investigator
Interstitial Lung Disease Department, Royal Brompton Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard prednisolone taper and Fast prednisolone taper in people with Sarcoidosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Kouranos (+44(0) 207 352 8121 ext. 84405, vasileios.kouranos@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving a prednisolone dose < 50% of baseline dose (time frame: From enrolment to 6 weeks after complete steroid wean or lowest prednisolone dose achieved). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.