A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

Göteborg University

Status and phase: Completed; Phase 4

Conditions: Addison Disease

Treatments: Drug: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03210545

DOSCORT

2016-004078-16 (EudraCT Number)

Details and patient eligibility

About

DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. Blood, saliva, urine, health related Quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.

Enrollment: 30 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females at ages 20-65 years
2. Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
3. A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
4. An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
5. If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
6. Body mass index (BMI) of 20-35 kg/m2
7. Ability to comply to the protocol procedures and having signed informed consent to participate in the study

Exclusion criteria

1. Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study
2. Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
3. Pregnant or lactating women
4. Diabetes Mellitus
5. Systemic infections
6. Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
7. Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
8. Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
9. Hypersensitivity to the active substance or any excipients used in the study drug of choice
10. Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids
11. Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

betamethasone - physiological dose

Active Comparator group

Description:

Replacing participants hydrocortisone with a daily dose of betamethasone in an estimated physiological dose during one treatment period.

Treatment:

Drug: Betamethasone

betamethasone - supra physiological dose

Active Comparator group

Description:

Replacing participants hydrocortisone with a daily dose of betamethasone in an estimated supra physiological dose during one treatment period.

Treatment:

Drug: Betamethasone