Actively Recruiting
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Led by Imperial College London · Updated on 2026-03-27
120
Participants Needed
1
Research Sites
402 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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, Cat's claw, Echinacea
- 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, 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
K
Katharine Lazarus, MBChB MRCP
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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