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

NCT05012033 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Thyroid Eye Disease
  • Vasculitis
  • COPD Exacerbation Acute
  • Asthma
  • Inflammatory Disease

Interventions

OTHER

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

Prednisolone given orally prior to taking timed samples for levels

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Karim Meeran, MBBS BSc MD · Imperial College London

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012033 on ClinicalTrials.gov