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

Launched by IMPERIAL COLLEGE LONDON · Aug 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes a medication called prednisolone in patients with various inflammatory conditions, such as thyroid eye disease, vasculitis, and asthma. The researchers want to understand the differences in prednisolone levels in patients who are taking it for a short time versus those who have been on it for a longer period. They will also look at how these levels change in patients who are switching between different steroid medications. The study involves three groups of participants, including those receiving high doses of prednisolone for less than five days, those on long-term high doses, and those starting a course of other steroid medications.

To be eligible for the study, participants must be between 18 and 75 years old and generally healthy enough to take part. Specifically, individuals in the first group need to require high-dose prednisolone for a short time, while those in the second group should have been on high doses for at least a month. Participants can expect to have their prednisolone levels measured at different times throughout the study, and additional tests will be done to assess any other changes in the body. It's important to note that individuals with diabetes or certain medical conditions, as well as those taking specific medications or supplements, may not be able to participate in the study.

Gender

ALL

Eligibility criteria

• 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.