Asthma Clinical Trial
— EHD-Pred PKOfficial title:
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
NCT number | NCT05012033 |
Other study ID # | 21HH6792 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 12, 2023 |
Est. completion date | March 26, 2026 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 26, 2026 |
Est. primary completion date | March 26, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Primary | To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose | This will be assessed by determination of Tmax | 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) | |
Primary | 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. | 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) | |
Primary | To elucidate differences in prednisolone pharmacokinetics (in patients receiving high dose | This will be assessed by determination of urinary steroid profiles. | 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 | 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 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) | |
Secondary | 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 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) | |
Secondary | Surrogate markers and risk factors for cardiovascular disease | Anthropometric markers such as blood pressure | On 1st and 2nd visits | |
Secondary | Surrogate markers and risk factors for cardiovascular disease | Anthropometric markers such as heart rate | On 1st and 2nd visits | |
Secondary | Surrogate markers and risk factors for cardiovascular disease | Anthropometric markers such as BMI | On 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years) | |
Secondary | Surrogate markers and risk factors for cardiovascular disease | Anthropometric markers such aswaist-hip circumference ratio. | On 1st and 2nd visits. This will be of variable duration depending on duration of steroid treatment (5 days up to 2 years) |
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