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

Sponsor
Imperial College London
Study ID
NCT05012033
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention - prednisolone is taken as part if routine clinical care. — OTHER
    Prednisolone given orally prior to taking timed samples for levels

Study Details

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 Dates

Start date
Apr 12, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Group A
    Patients started acutely on high dose prednisolone (\>30mg for any inflammatory condition)
  • Arm: Group B
    Patients on longer term anti-inflammatory doses of prednisolone to treat any medical condition warranting their use, including post COVID.
  • Arm: Group C
    Patients receiving multiple high doses of methylprednisolone or dexamethasone in association with oral prednisolone.

Primary Outcome Measure

To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose prednisolone acutely and in the chronic setting). [ 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) ]

Central Contacts

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