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Glucocorticoid Treatment in Addison's Disease

This study has been completed.
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: January 26, 2010
Last updated: March 19, 2013
Last verified: March 2013

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.

Condition Intervention Phase
Addison's Disease
Drug: Solu-Cortef (hydrocortisone)
Drug: Cortef (hydrocortisone)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glucocorticoid Treatment in Addison's Disease

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Morning (08-09) plasma ACTH [ Time Frame: Time 0, months 2, 3, 5, 7 and 8 ]

Secondary Outcome Measures:
  • Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores [ Time Frame: At time 0 and months 2,3,5,7 and 8 ]
  • Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary [ Time Frame: PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7 ]
  • 24h cortisol profiles in serum and saliva [ Time Frame: months 2 and 7 ]
  • S-glucose, 24 h profile [ Time Frame: months 2 and 7 ]
  • Insulin sensitivity assessed by euglycemic clamp [ Time Frame: Months 2 and 7 ]

Enrollment: 33
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral hydrocortisone Drug: Cortef (hydrocortisone)
Oral treatment 3 times a day. Weight adjusted doses.
Other Name: Cortef 5 mg
Experimental: Continous subcutaneous hydrocortisone infusion Drug: Solu-Cortef (hydrocortisone)
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Other Name: Solu-Cortef


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy.
  • Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01063569

Haukeland University Hospital
Bergen, Norway, 5021
Karolinska Institutet
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
Sponsors and Collaborators
Haukeland University Hospital
Principal Investigator: Kristian Løvås, MD,PhD Haukeland University Hospital
  More Information

Responsible Party: Haukeland University Hospital Identifier: NCT01063569     History of Changes
Other Study ID Numbers: 3.2007.2343
2009-010917-61 ( EudraCT Number )
Study First Received: January 26, 2010
Last Updated: March 19, 2013

Keywords provided by Haukeland University Hospital:
Addison's disease
Glucocorticoid treatment
Continuous subcutaneous hydrocortisone infusion
Quality of Life

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on March 29, 2017