Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorImperial College London
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients receiving high dose prednisolone for any inflammatory disorder.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
No intervention - prednisolone is taken as part if routine clinical care.
Other interventionPrednisolone given orally prior to taking timed samples for levels
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Group A1 intervention
Group B: Group B1 intervention
Group C: Group C1 intervention
Trial outcomes
Primary outcomes
1
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose prednisolone acutely and in the chronic setting).
This will be assessed by determination of Cmax
Time frame
Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)2
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of Tmax
Time frame
Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)3
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of prednisolone half life and area under the curve values.
Time frame
Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)4
To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose
This will be assessed by determination of urinary steroid profiles.
Time frame
Pharmacokinetics measurements taken at the first and second visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)Secondary outcomes
1
To elucidate further differences in metabolic profiles and glucocorticoid axis
Assessed by review of bloods, including full blood count (FBC), renal profile, liver function tests (LFTs), creatine kinase (CK), Adrenocorticotropic hormone (ACTH), cortisol, cortisol binding globulin (CBG) and bicarbonate.
Time frame
Time points post prednisolone dose at 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)2
Exploratory Outcomes
Metabolomic and metagenomic changes in plasma and urine to investigate inter-individual variation in prednisolone Immunology profiles - assessed by measurement and assessment of soluble immunological analytes and isolated white cell populations metabolism
Time frame
Time points post prednisolone dose at 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years)3
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as blood pressure
Time frame
On 1st and 2nd visits4
Surrogate markers and risk factors for cardiovascular disease
Anthropometric markers such as heart rate
Time frame
On 1st and 2nd visitsSponsors and contacts
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Source ClinicalTrials.gov