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Glucocorticoid Treatment in Addison's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01063569
First received: January 26, 2010
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glucocorticoid Treatment in Addison's Disease

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 24h cortisol profiles in serum and saliva [ Time Frame: months 2 and 7 ] [ Designated as safety issue: No ]
  • S-glucose, 24 h profile [ Time Frame: months 2 and 7 ] [ Designated as safety issue: No ]
  • Insulin sensitivity assessed by euglycemic clamp [ Time Frame: Months 2 and 7 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063569

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

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01063569     History of Changes
Other Study ID Numbers: 3.2007.2343, 2009-010917-61
Study First Received: January 26, 2010
Last Updated: March 19, 2013
Health Authority: Norway: Norwegian Medicines Agency
Norway: Regional Committee for Medical and Health Research Ethics, Western Norway
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone
Hydrocortisone-17-butyrate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013