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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Katharine Lazarus, MBChB MRCP
imperial.steroids@nhs.net
07555717544
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2026-03-26
Participants
Target number of participants: 120
Treatments
Group A
Patients started acutely on high dose prednisolone (\>30mg for any inflammatory condition)
Group B
Patients on longer term anti-inflammatory doses of prednisolone to treat any medical condition warranting their use, including post COVID.
Group C
Patients receiving multiple high doses of methylprednisolone or dexamethasone in association with oral prednisolone.
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov

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