Effects of modified release hydrocortisone on restoration of early morning cortisol, quality of life, and fatigue in adrenal insufficiency (The CHAMPAIN study): a randomised, double-blind, double-dummy, cross-over study comparing Chronocort and Plenadren.

ABSTRACT:

Background

Cortisol has a circadian rhythm with an early morning rise, loss of this rhythm is associated with poor health. Our objective was to test the hypothesis that restoring the early morning cortisol rise will improve fatigue and quality of life (QoL) by comparing twice daily Chronocort with once daily Plenadren in patients with adrenal insufficiency.

Methods

A randomised, double-blind, double-dummy, cross-over study with no washout in 58 patients (29 in each arm) with primary adrenal insufficiency comparing four weeks' Chronocort, 15 mg at night and 10 mg in the morning, a formulation that restores early morning cortisol levels, with four weeks' once daily Plenadren 25 mg, which only restores daytime cortisol levels. The primary endpoint was the 07:00 h serum cortisol

SUBMITTER: Prete A 

PROVIDER: S-EPMC12805350 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature