Glucocorticoid Treatment in Addison's Disease - Full Text View

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:

Genetics Home Reference related topics: autoimmune Addison disease familial glucocorticoid deficiency

MedlinePlus related topics: Addison Disease Steroids

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

Genetic and Rare Diseases Information Center resources: Addison's Disease Hypoadrenalism

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Hydrocortisone 17-butyrate 21-propionate Cortisol succinate	Hydrocortisone acetate Hydrocortisone Glucocorticoids Anti-Inflammatory Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016