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

Launched by ULLA FELDT-RASMUSSEN · Jun 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how supplemental hydrocortisone, a medication that helps replace cortisol in the body, affects people with adrenal insufficiency who are already taking a low dose of prednisolone. The researchers want to see if adding hydrocortisone can improve the quality of life, particularly focusing on fatigue during times of physical or mental stress. This study is specifically looking at patients with polymyalgia rheumatica (PMR) or giant cell arteritis (GCA), both of which are inflammatory conditions that can cause pain and stiffness.

To participate in this trial, you need to be at least 50 years old, postmenopausal if you're a woman, and have been diagnosed with PMR or GCA while currently taking prednisolone for at least 12 weeks. Participants must also be on a stable low dose of prednisolone. During the trial, participants will be randomly assigned to receive either hydrocortisone or a placebo (a harmless pill that looks the same but has no active medication) without knowing which one they receive. This helps the researchers fairly assess the effects of hydrocortisone. It's important to note that some health conditions and medications can exclude individuals from participating, so if you're interested, you should discuss this with your doctor to see if you meet the requirements.

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Eligibility 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.