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Glucocorticoid Treatment in Addison's Disease

Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Addison's Disease

Intervention: Solu-Cortef (hydrocortisone) (Drug); Cortef (hydrocortisone) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Haukeland University Hospital

Official(s) and/or principal investigator(s):
Kristian Løvås, MD,PhD, Principal Investigator, Affiliation: Haukeland University Hospital


Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives. The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.

Clinical Details

Official title: Glucocorticoid Treatment in Addison's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Morning (08-09) plasma ACTH

Secondary outcome:

Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores

Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary

24h cortisol profiles in serum and saliva

S-glucose, 24 h profile

Insulin sensitivity assessed by euglycemic clamp


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- Patients with verified Addison's disease on stable treatment.

Exclusion Criteria:

- Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease,


- Treatment with glucocorticoids or drugs that interfere with cortisol metabolism

(antiepileptics, rifampicin, St. John's wart).

Locations and Contacts

Haukeland University Hospital, Bergen 5021, Norway

Karolinska Institutet, Stockholm, Sweden

Uppsala University, Uppsala, Sweden

Additional Information

Starting date: February 2010
Last updated: March 19, 2013

Page last updated: August 23, 2015

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