At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- No intervention - prednisolone is taken as part if routine clinical care. (other)
- How long the study runs
- Study runs about 92 months (dates as stated)
- About the drug or intervention
- No intervention - prednisolone is taken as part if routine clinical care. — other: Prednisolone given orally prior to taking timed samples for levels
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 120
- Started
- 2023-04-12
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for thyroid eye disease
- • Clinical study - 120 participants
- • 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
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with thyroid eye disease
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓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 agreement to take part to participate in the study
- ✓Group A only: Patients requiring acute (\<5 days) high dose (minimum 30mg) oral prednisolone therapy for...
Who cannot take part
- ✗Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
- ✗Unable to give agreement to take part.
- ✗Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London, United Kingdom
How to Get in Touch
Katharine Lazarus, MBChB MRCP
Sponsor contactCONTACT