Recruiting

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

ClinicalTrials.gov IDNCT05012033

PhaseNot Applicable

Enrollment120

SponsorImperial College London

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

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

Primary outcomes

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

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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 (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties). * 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 or 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.

Study locations

Imperial College Healthcare NHS Trust, London, United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.