RecruitingNCT05012033

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

Sponsor

Imperial College London

Enrollment

120 participants

Start Date

Apr 12, 2023

Study Type

OBSERVATIONAL

Conditions

Asthma Vasculitis Inflammatory Disease Thyroid Eye Disease COPD Exacerbation Acute

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study examines how the body absorbs and processes high-dose prednisolone (a steroid) when taken for short bursts (like during a flare-up) versus long-term. The goal is to better understand how this commonly prescribed medication works in different situations. **You may be eligible if...** - You are between 18 and 75 years old - You are in generally good health - Group A: You need a short course (less than 5 days) of high-dose oral prednisolone (at least 30mg) for an inflammatory condition - Group B: You have been on high-dose oral prednisolone for at least one month for an inflammatory condition - You are willing to give informed consent and attend study visits **You may NOT be eligible if...** - You are outside the age range of 18–75 - You have a medical condition that makes participation unsafe - You are unable or unwilling to follow the study schedule - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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