Glucocorticoid Treatment in Addison's Disease

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ClinicalTrials.gov Identifier: NCT01063569

Recruitment Status : Completed

First Posted : February 5, 2010

Last Update Posted : March 20, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Haukeland University Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Addison's Disease	Drug: Solu-Cortef (hydrocortisone) Drug: Cortef (hydrocortisone)	Phase 2 Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	33 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Glucocorticoid Treatment in Addison's Disease
Study Start Date :	February 2010
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Autoimmune Addison disease

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

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063569

Locations

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Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sweden
Karolinska Institutet
Stockholm, Sweden
Uppsala University
Uppsala, Sweden

Sponsors and Collaborators

Haukeland University Hospital

Investigators

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Principal Investigator:	Kristian Løvås, MD,PhD	Haukeland University Hospital

More Information

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Responsible Party:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT01063569
Other Study ID Numbers:	3.2007.2343 2009-010917-61 ( EudraCT Number )
First Posted:	February 5, 2010 Key Record Dates
Last Update Posted:	March 20, 2013
Last Verified:	March 2013

Keywords provided by Haukeland University Hospital:


Addison's disease Glucocorticoid treatment Continuous subcutaneous hydrocortisone infusion	CSHI Quality of Life Sleep

Additional relevant MeSH terms:

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Addison Disease Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases	Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Anti-Inflammatory Agents

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