Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorImperial College London
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- No intervention - prednisolone is taken as part if routine clinical care.
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov