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RECRUITING
NCT05012033

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

Sponsor: Imperial College London

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-04-12

Completion Date

2030-12-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

OTHER

No intervention - prednisolone is taken as part if routine clinical care.

Prednisolone given orally prior to taking timed samples for levels

Locations (1)

Imperial College Healthcare NHS Trust

London, United Kingdom