Evaluating how high doses of prednisolone affect patients with inflammatory conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the serum prednisolone profiles in patients receiving high doses of prednisolone for various inflammatory disorders, both acutely and chronically. It includes three groups: those starting high doses acutely, those on chronic high doses, and those transitioning from high dose methylprednisolone or dexamethasone. The study aims to measure prednisolone levels at multiple time points to identify differences in serum profiles and metabolic changes associated with different dosing regimens. The ultimate goal is to understand how prednisolone metabolism varies with dosage and duration of treatment.

Why it matters

Who can join: the full rules

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's running

• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Karim Meeran, MBBS BSc MD — Imperial College London
• Study coordinator: Katharine Lazarus, MBChB MRCP
• Email: imperial.steroids@nhs.net
• Phone: 07555717544

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.