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

NCT ID: NCT03210545

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2022-02-16

Brief Summary

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.

Conditions

Addison Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

betamethasone - physiological dose

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

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

A cross-over study where patients with Addison´s disease will undergo two treatment periods where their usual hydrocortisone replacement therapy will be replaced by the glucocorticoid betamethasone in physiological and supra physiological doses. A wash-out period of 2-5 weeks in-between the treatment periods will be carried out where participants intake their usual hydrocortisone replacement therapy.

betamethasone - supra physiological dose

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

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

A cross-over study where patients with Addison´s disease will undergo two treatment periods where their usual hydrocortisone replacement therapy will be replaced by the glucocorticoid betamethasone in physiological and supra physiological doses. A wash-out period of 2-5 weeks in-between the treatment periods will be carried out where participants intake their usual hydrocortisone replacement therapy.

Interventions

Betamethasone

A cross-over study where patients with Addison´s disease will undergo two treatment periods where their usual hydrocortisone replacement therapy will be replaced by the glucocorticoid betamethasone in physiological and supra physiological doses. A wash-out period of 2-5 weeks in-between the treatment periods will be carried out where participants intake their usual hydrocortisone replacement therapy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gudmundur Johannsson, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region, Sahlgrenska University Hospital, dept. of Endocrinology

Locations

Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

2016-004078-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DOSCORT

Identifier Type: -

Identifier Source: org_study_id