NCT03936517

Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study compares low-dose prednisolone therapy against standard regimens of hydrocortisone therapy for the treatment of adrenal insufficiency (AI). AI is a condition in which, individuals are unable to sufficiently produce the natural stress hormone, cortisol.

Detailed description

Steroid replacement therapy is vital for the health of patients with adrenal insufficiency (AI), who are unable to produce the natural stress hormone, cortisol. The objectives of steroid replacement therapy are to replace the body's physiological requirements for cortisol without over-replacement and consequent Cushing's syndrome. Equally, under-replacement presents the risk of patients experiencing potentially fatal Addisonian crises. Appropriately replacing a patient's steroid requirement is a significant challenge. Hydrocortisone (HC) is used in the majority of patients with AI in the UK. However, HC has a short duration of action, necessitating dosing 3 times a day. Low-dose prednisolone (PR) is an alternative to HC which needs only once-daily. There have been no studies directly comparing low-dose PR to HC treatment. This is a two-arm, two-period, double-blind, randomised, cross-over study comparing the low dose PR and standard regimens of HC in the treatment of AI.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Prednisolone	Low dose prednisolone for the treatment of adrenal insufficiency. Usually administered once daily
DRUG	Hydrocortisone	Standard regimens of hydrocortisone for the treatment of adrenal insufficiency. Usually administered thrice daily.

Timeline

• Start date: 2019-07-31
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2019-05-03
• Last updated: 2023-09-01

Locations

1 site across 1 country: United Kingdom