An observational study in Thyroid Eye Disease, Vasculitis and COPD Exacerbation Acute, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Imperial College London · Observational
This is a pilot study to investigate serum prednisolone profiles in:
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.
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.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 45 observational studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients receiving high dose prednisolone for any inflammatory disorder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients started acutely on high dose prednisolone (\>30mg for any inflammatory condition)
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.
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.
Other: No intervention - prednisolone is taken as part if routine clinical care.
Prednisolone given orally prior to taking timed samples for levels
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
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)
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of Tmax
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)
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.
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)
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of urinary steroid profiles.
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)
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.
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
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
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
Anthropometric markers such as blood pressure
Time frame: On 1st and 2nd visits
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as heart rate
Time frame: On 1st and 2nd visits
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as BMI
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
Anthropometric markers such aswaist-hip circumference ratio.
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)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2030, 92 months after the start.
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