RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency.

Phase 1

• Conditions: Glucocorticoid-induced adrenal insufficiency; MedDRA version: 20.0Level: LLTClassification code 10001369Term: Adrenal insufficiency NOSSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-002528-18-DK
• Lead Sponsor: Copenhagen University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-30
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 325

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 163

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. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified