Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM) (DREAM)
Primary Adrenal Insufficiency, Secondary Adrenal Insufficiency
About this trial
This is an interventional treatment trial for Primary Adrenal Insufficiency focused on measuring Plenadren, Addison's disease, Hydrocortisone, Cortisone Acetate, Monocytes, Natural Killer cells, Immunological profile, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Previously diagnosed (e.g. more than 6 months ago) primary or secondary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry
- Signed informed consent to participate in the study
Exclusion Criteria:
- acute primary or secondary adrenal insufficiency
- clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease
- clinically significant renal dysfunction
- any medication with agents which could interfere with glucocorticoid kinetics
Sites / Locations
- Department of Experimental Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Plenadren
Conventional glucocorticoid therapy
Healthy volunteers
Plenadren (modified release hydrocortison) 20-25 or 30 mg oral tablets will be administered once-daily at 8.00 AM in the fasting state The dose is kept the same as patients had before entering the trial.
Hydrocortisone (dose range 10 to 30) mg will be continued as before entering the study. Cortisone Acetate (dose 25 to 37.5 mg) will be continued as before entering the study. The morning dose will be administered in the fasting state. The total daily dose and timing is not changed during the study period.
Healthy volunteers will be enrolled as control group