Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-27

Study Completion Date

2017-12-31

Brief Summary

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The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

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Detailed Description

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The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) and congenital adrenal hyperplasia renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach does not enable to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of glucocorticoids leads to abnormal gene transcription and causes sides effect of glucocorticoids treatment and long standing complications Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, which can mimic not only the normal diurnal cortisol rhythm, but potentially also the ultradian cadence.

This is a pilot trial with an open cross-over design of 3 x minimum 2 weeks in 10 patients comparing the effects of tablet treatment versus continuous subcutaneous hydrocortisone infusion versus ultradian subcutaneous hydrocortisone infusion on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.

Conditions

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Addison Disease Adrenal Hyperplasia Congenital

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous subcutaneous hydrocortisone

continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate

Group Type EXPERIMENTAL

Solu-Cortef

Intervention Type DRUG

administration by pump for minimum 2 weeks

Cortef

Intervention Type DRUG

tablet treatment 2 ro 3 times per day for 14 days

cortef tablets

the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.

Group Type ACTIVE_COMPARATOR

Solu-Cortef

Intervention Type DRUG

administration by pump for minimum 2 weeks

Cortef

Intervention Type DRUG

tablet treatment 2 ro 3 times per day for 14 days

ultradian subcutaneous hydrocortisone

ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate

Group Type EXPERIMENTAL

Solu-Cortef

Intervention Type DRUG

administration by pump for minimum 2 weeks

Cortef

Intervention Type DRUG

tablet treatment 2 ro 3 times per day for 14 days

Interventions

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Solu-Cortef

administration by pump for minimum 2 weeks

Intervention Type DRUG

Cortef

tablet treatment 2 ro 3 times per day for 14 days

Intervention Type DRUG

Other Intervention Names

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hydrocortisone hydrocortisone tablets

Eligibility Criteria

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Inclusion Criteria

1. clinical diagnosis of primary adrenal insufficiency
2. Written informed consent

Exclusion Criteria

1. Diabetes mellitus
2. Severe cardiovascular disease
3. Active malignant disease
4. Pregnancy or breast feeding
5. treatment with interfering drugs
6. Intake of grapefruit juice

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No