Addison DiseasePhase 4NCT03210545
A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)
A Phase 4 study testing Betamethasone in people with Addison Disease, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Addison Disease
- What is being tested?
- Betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 2 Mar 2021to 16 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at ages 20-65 years
- Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
- A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
- An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
- If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
- Body mass index (BMI) of 20-35 kg/m2
- Ability to comply to the protocol procedures and having signed informed consent to participate in the study
Who cannot join
- 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
- Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
- Pregnant or lactating women
- Diabetes Mellitus
- Systemic infections
- Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
Show all 11Show fewer
- Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
- Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
- Hypersensitivity to the active substance or any excipients used in the study drug of choice
- 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
- Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Gothenburg, 413 45
About this study
Official title: A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Double-blinded, Randomized, 2-dose, Cross-over Study
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
- Being tested
- Betamethasone
- Keywords
- Biomarker, Glucocorticoids, Metabolism
- Medical subject headings
- Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| betamethasone - physiological dose | Active comparator | Replacing participants hydrocortisone with a daily dose of betamethasone in an estimated physiological dose during one treatment period. Receives: Drug: Betamethasone |
| betamethasone - supra physiological dose | Active comparator | Replacing participants hydrocortisone with a daily dose of betamethasone in an estimated supra physiological dose during one treatment period. Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein profile changes between physiological and supra physiological doses of betamethasone.
By using mas spectrometry, protein profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Measured: Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone
Metabolite profile changes between physiological and supra physiological doses of betamethasone.
By using mas spectrometry, metabolite profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Measured: Changes in metabolome (units depending on the kind of metabolome) during 7 days of treatment with two different doses of betamethasone
Secondary outcomes (10)
Messenger RNA (mRNA)/miRNA profile changes between physiological and supra physiological doses of betamethasone.
By using array based transcriptomics (both mRNA and miRNA), mRNA/miRNA profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Measured: Changes in mRNA/miRNA (Svedberg Unit, S) during 7 days of treatment with two different doses of betamethasone
Changes in glucose metabolism between physiological and supra physiological doses of betamethasone.
Conventional markers for glucose metabolism in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Measured: Changes in glucose metabolism (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone
Changes in lipid-profile between physiological and supra physiological doses of betamethasone.
Conventional markers for lipid-profile in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Measured: Changes in lipid-profile (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone
Changes in bone-markers between physiological and supra physiological doses of betamethasone.
Bone-markers in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Measured: Changes in levels of bone-markers in blood (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone
Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Addison-specific Quality of Life questionnaire (ADDIQoL).
Self-reported health-related quality of life and general well-being will be assessed using the ADDIQoL questionnaire after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.
Measured: Changes in units of the ADDIQoL questionnaire (units on a scale) after 7 days of treatment with two different doses of betamethasone
Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Psychological General Well-being (PGWB) index.
Self-reported health-related quality of life and general well-being will be assessed using the PGWB index after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.
Measured: Changes in units of the PGWB index (units on a scale) after 7 days of treatment with two different doses of dexamethasone
Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Fatigue impact scale (FIS)
Self-reported health-related quality of Life, general well-being and fatigue will be assessed using the FIS questionnaire after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.
Measured: Changes in units in the FIS (units on a scale) after 7 days of treatment with two different doses of betamethasone
Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Functional Outcomes of Sleep Questionnaire (FOSQ).
Self-reported health-related quality of life, general well-being and fatigue will be assessed using FOSQ after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.
Measured: Changes in units in the FOSQ (units on a scale) after 7 days of treatment with two different doses of betamethasone
Changes in daily physical activity between physiological and supra physiological doses of betamethasone
Daily physical activity will be objectively evaluated using a wrist accelerometer during 7 days of treatment with a physiological dose of betamethasone and during 7 days of treatment with a supra physiological dose of betamethasone.
Measured: Changes in daily physical activity (units provided in connected software) after 7 days of treatment with two different doses of betamethasone
Changes in sleep quality between physiological and supra physiological doses of betamethasone
Sleep quality will be objectively evaluated using a wrist worn sleep monitor during the last night of a 7 day treatment period with a physiological dose of betamethasone and the last night of a 7 day treatment period with a supra physiological dose of betamethasone.
Measured: Changes in sleep quality (measurements and units provided in connected software) after 7 days of treatment with two different doses of betamethasone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start2 Mar 2021
- Primary completion9 Nov 2021
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addison DiseaseStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gudmundur Johannsson, Prof., MD, Principal investigator, Vastra Gotaland Region, Sahlgrenska University Hospital, dept. of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210545
- Sponsor's protocol ID
- DOSCORT
- Other IDs
- 2016-004078-16, 2016
- Status last verified
- Apr 2025
- First submitted
- 29 Jun 2017
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Double-blinded, Randomized, 2-dose, Cross-over Study
- ClinicalTrials.gov ID
- NCT03210545
- Acronym / sponsor ID
- DOSCORT
- Conditions
- Addison Disease
- Keywords
- Biomarker, Glucocorticoids, Metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| betamethasone - physiological dose | Active comparator | Drug: BetamethasoneReplacing participants hydrocortisone with a daily dose of betamethasone in an estimated physiological dose during one treatment period. |
| betamethasone - supra physiological dose | Active comparator | Drug: BetamethasoneReplacing participants hydrocortisone with a daily dose of betamethasone in an estimated supra physiological dose during one treatment period. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females at ages 20-65 years
- Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
- A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
- An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
- If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
Key exclusion criteria (11 listed)
- 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
- Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
- Pregnant or lactating women
- Diabetes Mellitus
- Systemic infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetamethasoneA 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. | Drug | betamethasone - physiological dose, betamethasone - supra physiological dose |
Primary outcome
Protein profile changes between physiological and supra physiological doses of betamethasone.
Time frame: Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone
By using mas spectrometry, protein profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
Metabolite profile changes between physiological and supra physiological doses of betamethasone.
Time frame: Changes in metabolome (units depending on the kind of metabolome) during 7 days of treatment with two different doses of betamethasone
By using mas spectrometry, metabolite profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.
10 secondary outcomes
Messenger RNA (mRNA)/miRNA profile changes between physiological and supra physiological doses of betamethasone.
Time frame: Changes in mRNA/miRNA (Svedberg Unit, S) during 7 days of treatment with two different doses of betamethasone
Changes in glucose metabolism between physiological and supra physiological doses of betamethasone.
Time frame: Changes in glucose metabolism (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone
Changes in lipid-profile between physiological and supra physiological doses of betamethasone.
Time frame: Changes in lipid-profile (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone
Changes in bone-markers between physiological and supra physiological doses of betamethasone.
Time frame: Changes in levels of bone-markers in blood (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone
Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Addison-specific Quality of Life questionnaire (ADDIQoL).
Time frame: Changes in units of the ADDIQoL questionnaire (units on a scale) after 7 days of treatment with two different doses of betamethasone
Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Psychological General Well-being (PGWB) index.
Time frame: Changes in units of the PGWB index (units on a scale) after 7 days of treatment with two different doses of dexamethasone
Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Fatigue impact scale (FIS)
Time frame: Changes in units in the FIS (units on a scale) after 7 days of treatment with two different doses of betamethasone
Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Functional Outcomes of Sleep Questionnaire (FOSQ).
Time frame: Changes in units in the FOSQ (units on a scale) after 7 days of treatment with two different doses of betamethasone
Changes in daily physical activity between physiological and supra physiological doses of betamethasone
Time frame: Changes in daily physical activity (units provided in connected software) after 7 days of treatment with two different doses of betamethasone
Changes in sleep quality between physiological and supra physiological doses of betamethasone
Time frame: Changes in sleep quality (measurements and units provided in connected software) after 7 days of treatment with two different doses of betamethasone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Addison Disease
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Recruiting
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Cushing Syndrome, Adrenal Insufficiency
RecruitingObservational study
Natural History of Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)
Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gudmundur Johannsson, Prof., MD principal investigator
Vastra Gotaland Region, Sahlgrenska University Hospital, dept. of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethasone in people with Addison Disease, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein profile changes between physiological and supra physiological doses of betamethasone. (time frame: Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.