Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
NCT ID: NCT05012033
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-04-12
2026-03-26
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Group A
Patients started acutely on high dose prednisolone (\>30mg for any inflammatory condition)
No intervention - prednisolone is taken as part if routine clinical care.
Prednisolone given orally prior to taking timed samples for levels
Group B
Patients on longer term anti-inflammatory doses of prednisolone to treat any medical condition warranting their use, including post COVID.
No intervention - prednisolone is taken as part if routine clinical care.
Prednisolone given orally prior to taking timed samples for levels
Group C
Patients receiving multiple high doses of methylprednisolone or dexamethasone in association with oral prednisolone.
No intervention - prednisolone is taken as part if routine clinical care.
Prednisolone given orally prior to taking timed samples for levels
Interventions
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No intervention - prednisolone is taken as part if routine clinical care.
Prednisolone given orally prior to taking timed samples for levels
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Karim Meeran, MBBS BSc MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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21HH6792
Identifier Type: -
Identifier Source: org_study_id
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