Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Recruiting · NCT05012033 · Observational (researchers observe without assigning treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed.
- Imperial College Healthcare NHS Trust - London, United Kingdom
- Imperial College Healthcare NHS Trust - London, United Kingdom