Evaluating how high doses of prednisolone affect patients with inflammatory conditions
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
This study is trying to see how different doses of prednisolone affect patients with inflammatory conditions by looking at their blood levels and how their bodies process the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05012033 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 who require high dose prednisolone therapy for inflammatory conditions.
Not a fit: Patients with diabetes mellitus or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored dosing of prednisolone, potentially reducing side effects for patients.
How similar studies have performed: While there have been studies on prednisolone, this specific approach to evaluating serum profiles in high dose settings is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.