Actively Recruiting
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Led by Imperial College London · Updated on 2026-03-27
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how prednisolone, a common anti-inflammatory drug used for conditions like asthma, allergy, and autoimmune diseases, is processed in the body when given at high doses. This study focuses on patients receiving high-dose prednisolone in both short-term (acute) and long-term (chronic) settings. The aim is to better understand differences in drug levels over time and metabolic changes, which may help tailor dosing to reduce side effects and improve treatment safety. The study involves three groups: patients starting high-dose prednisolone acutely either in hospital or outpatient settings; those on long-term high-dose prednisolone; and patients receiving high doses of methylprednisolone or dexamethasone alongside oral prednisolone. Participants will continue their usual prednisolone treatment as part of routine care. Blood samples will be taken at various times to measure prednisolone levels and study metabolic effects. Participants will attend at least two visits where blood samples and other assessments will be done, with the timing depending on the duration of steroid treatment, ranging from 5 days up to 2 years. Researchers will monitor prednisolone pharmacokinetics and metabolic markers related to cardiovascular risk. The study includes detailed medical history, pregnancy testing for women of childbearing age, and regular follow-up to understand drug metabolism and effects over time.
CONDITIONS
Brief Title
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 anti-inflammatory 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
You will not qualify if you...
- 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, Cat's claw, Echinacea
- 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 would interfere with the study or compromise participant safety as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days up to 2 years depending on steroid treatment duration
Participants who undergo routine clinical care with prednisolone are observed to study prednisolone pharmacokinetics and metabolic profiles.
2 visits for pharmacokinetics measurements and assessments
Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
K
Katharine Lazarus, MBChB MRCP
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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