Thyroid Eye DiseaseEHD-Pred PKNCT05012033
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
An observational study of Thyroid Eye Disease and Vasculitis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is a pilot study to investigate serum prednisolone profiles in: Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting. Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease, Vasculitis, COPD Exacerbation Acute
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Apr 2023to 31 Dec 2030
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving high dose prednisolone for any inflammatory disorder.
Who may be able to join
- Aged 18 - 75 years
- Male or female
- Participants who are otherwise healthy enough to participate, as determined by pre-study medical history
- Participants who are able and willing to give written informed consent to participate in the study
- Group A only: Patients requiring acute (<5 days) high dose (minimum 30mg) oral prednisolone therapy for antiinflammatory purposes in either an inpatient or outpatient setting.
- Group B only: Minimum of 1 month duration of high dose prednisolone (>30mg) if in the chronic use group.
- Group C only: Patients started on high dose methylprednisolone (>3 day course) or prolonged courses of dexamethasone.
Who cannot join
- Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
- Unable to give informed consent.
- Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
- Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
- Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.
- History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
About this study
This is a pilot study to investigate serum prednisolone profiles in:
- Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting.
- Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone.
Read more
The study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone.
The study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.
Read the detailed description
Prednisolone is an anti-inflammatory drug widely used to reduce inflammation and immune activation in a number of medical conditions, including asthma, allergy, inflammatory and auto-immune conditions. Its therapeutic actions, however, are accompanied by several adverse side effects, which are more frequent following high doses and long term treatments. The aim is therefore to use the lowest effective dose or highest dose for the shortest treatment required.
It has been observed in a select number of patients on replacement prednisolone doses for adrenal insufficiency (AI) that serum prednisolone levels change over time, despite patients remaining on the same dose. It is currently unclear whether serum levels of prednisolone match the doses in patients taking high dose prednisolone, both in the acute and chronic setting, and whether the way in which prednisolone is metabolised is altered after receiving high doses for prolonged periods of time.
The rationale for the use of particular doses for particular conditions is not clear, and has been developed historically in the absence of individual patient data. It is possible that more tailored dosing of prednisolone will result in reduced side effects, and that the minimum possible dose may be weight related.
In addition, genetic and epigenetic factors may also play a role in the efficacy of prednisolone and in the risk of developing side effects, accounting for some of the inter-individual variation in drug response.
Further characterising this may help to create an evidence base to tailor anti-inflammatory doses and weaning regimens of synthetic glucocorticoids that avoid deleterious effects.
- Being tested
- No intervention - prednisolone is taken as part if routine clinical care.
- Medical subject headings
- Graves Ophthalmopathy, Vasculitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - prednisolone is taken as part if routine clinical care.Other
Prednisolone given orally prior to taking timed samples for levels
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients started acutely on high dose prednisolone (>30mg for any inflammatory condition) Receives: Other: No intervention - prednisolone is taken as part if routine clinical care. | |
| Group B | Patients on longer term anti-inflammatory doses of prednisolone to treat any medical condition warranting their use, including post COVID. Receives: Other: No intervention - prednisolone is taken as part if routine clinical care. | |
| Group C | Patients receiving multiple high doses of methylprednisolone or dexamethasone in association with oral prednisolone. Receives: Other: No intervention - prednisolone is taken as part if routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose prednisolone acutely and in the chronic setting).
This will be assessed by determination of Cmax
Measured: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of Tmax
Measured: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of prednisolone half life and area under the curve values.
Measured: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of urinary steroid profiles.
Measured: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Secondary outcomes (6)
To elucidate further differences in metabolic profiles and glucocorticoid axis
Assessed by review of bloods, including full blood count (FBC), renal profile, liver function tests (LFTs), creatine kinase (CK), Adrenocorticotropic hormone (ACTH), cortisol, cortisol binding globulin (CBG) and bicarbonate.
Measured: Time points post prednisolone dose at 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Exploratory Outcomes
Metabolomic and metagenomic changes in plasma and urine to investigate inter-individual variation in prednisolone Immunology profiles - assessed by measurement and assessment of soluble immunological analytes and isolated white cell populations
metabolism
Measured: Time points post prednisolone dose at 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as blood pressure
Measured: On 1st and 2nd visits
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as heart rate
Measured: On 1st and 2nd visits
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as BMI
Measured: On 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such aswaist-hip circumference ratio.
Measured: On 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start12 Apr 2023
- Primary completionDec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Meeran, MBBS BSc MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012033
- Sponsor's protocol ID
- 21HH6792
- Acronym
- EHD-Pred PK
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2021
- 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
- Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
- ClinicalTrials.gov ID
- NCT05012033
- Acronym / sponsor ID
- EHD-Pred PK / 21HH6792
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Aug 2021 (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.
This is a pilot study to investigate serum prednisolone profiles in:
- Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting.
- Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone.
The study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone.
The study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.
Detailed description
Prednisolone is an anti-inflammatory drug widely used to reduce inflammation and immune activation in a number of medical conditions, including asthma, allergy, inflammatory and auto-immune conditions. Its therapeutic actions, however, are accompanied by several adverse side effects, which are more frequent following high doses and long term treatments. The aim is therefore to use the lowest effective dose or highest dose for the shortest treatment required.
It has been observed in a select number of patients on replacement prednisolone doses for adrenal insufficiency (AI) that serum prednisolone levels change over time, despite patients remaining on the same dose. It is currently unclear whether serum levels of prednisolone match the doses in patients taking high dose prednisolone, both in the acute and chronic setting, and whether the way in which prednisolone is metabolised is altered after receiving high doses for prolonged periods of time.
The rationale for the use of particular doses for particular conditions is not clear, and has been developed historically in the absence of individual patient data. It is possible that more tailored dosing of prednisolone will result in reduced side effects, and that the minimum possible dose may be weight related.
In addition, genetic and epigenetic factors may also play a role in the efficacy of prednisolone and in the risk of developing side effects, accounting for some of the inter-individual variation in drug response.
Further characterising this may help to create an evidence base to tailor anti-inflammatory doses and weaning regimens of synthetic glucocorticoids that avoid deleterious effects.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: No intervention - prednisolone is taken as part if routine clinical care.Patients started acutely on high dose prednisolone (>30mg for any inflammatory condition) |
| Group B | – | Other: No intervention - prednisolone is taken as part if routine clinical care.Patients on longer term anti-inflammatory doses of prednisolone to treat any medical condition warranting their use, including post COVID. |
| Group C | – | Other: No intervention - prednisolone is taken as part if routine clinical care.Patients receiving multiple high doses of methylprednisolone or dexamethasone in association with oral prednisolone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving high dose prednisolone for any inflammatory disorder.
Key inclusion criteria (7 listed)
- Aged 18 - 75 years
- Male or female
- Participants who are otherwise healthy enough to participate, as determined by pre-study medical history
- Participants who are able and willing to give written informed consent to participate in the study
- Group A only: Patients requiring acute (<5 days) high dose (minimum 30mg) oral prednisolone therapy for antiinflammatory purposes in either an inpatient or outpatient setting.
Key exclusion criteria (6 listed)
- Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
- Unable to give informed consent.
- Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
- Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
- Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.
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 |
|---|---|---|
| No intervention - prednisolone is taken as part if routine clinical care.Prednisolone given orally prior to taking timed samples for levels | Other | Group A, Group B, Group C |
Primary outcome
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose prednisolone acutely and in the chronic setting).
Time frame: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
This will be assessed by determination of Cmax
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
Time frame: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
This will be assessed by determination of Tmax
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
Time frame: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
This will be assessed by determination of prednisolone half life and area under the curve values.
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
Time frame: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
This will be assessed by determination of urinary steroid profiles.
6 secondary outcomes
To elucidate further differences in metabolic profiles and glucocorticoid axis
Time frame: Time points post prednisolone dose at 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Exploratory Outcomes
Time frame: Time points post prednisolone dose at 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Surrogate markers and risk factors for cardiovascular disease
Time frame: On 1st and 2nd visits
Surrogate markers and risk factors for cardiovascular disease
Time frame: On 1st and 2nd visits
Surrogate markers and risk factors for cardiovascular disease
Time frame: On 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
Surrogate markers and risk factors for cardiovascular disease
Time frame: On 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)
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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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.
Karim Meeran, MBBS BSc MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Eye Disease and Vasculitis, run by Imperial College London 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 7 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 Katharine Lazarus, MBChB MRCP (07555717544, imperial.steroids@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose prednisolone acutely and in the chronic setting). (time frame: Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)). The study lists 4 primary outcomes in all. 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.