Overview

Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

Status:
Recruiting
Trial end date:
2028-03-01
Target enrollment:
0
Participant gender:
All
Summary
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ulla Feldt-Rasmussen
Collaborators:
Aarhus University Hospital
Odense University Hospital
Treatments:
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Criteria
Inclusion Criteria:

- Age ≥ 50 years

- Women must be postmenopausal (FSH is measured at the screening visit)

- A diagnosis of PMR/GCA, or both conditions combined.

- Treatment with prednisolone ≥12 weeks

- Ongoing prednisolone treatment, with current daily prednisolone dose > 0 mg and ≤5 mg.
The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.

Exclusion Criteria:

- Known primary or secondary adrenal insufficiency

- Known Cushing's Syndrome

- Known allergy towards study medication ingredients

- Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney
failure with an estimated glomerular filtration rate <30 mL/min (Chronic kidney
disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known
severe immune deficiency; A history of psychiatric disease requiring treatment by a
psychiatric department (for affective disorders only if within the last year before
study entry)

- Alcohol consumption >21 units per week

- Planned major surgery during the study period at study entry.

- Use of drugs that interfere with cortisol metabolism/measurements: Systemic oestrogen
treatment (discontinued < 1 month before inclusion), Treatment with strong CYP3A4
inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled
corticosteroids, intraarticular or intramuscular injections, steroid creams European
steroid group IV-V used in the genital area. Note: Permitted glucocorticoid
formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group
I-III, and European steroid group IV-V used in the non-genital area only.)

- Inability to provide written informed consent.