Addison's disease and Congenital Adrenal Hyperplasia MedDRA version: 17.0 Level: LLT Classification code 10011195 Term: Cortisol System Organ Class: 100000004848 MedDRA version: 17.0 Level: LLT Classification code 10020518 Term: Hydrocortisone System Organ Class: 100000004848
Conditions
Interventions
Trade Name: hydrocortisone sodium phosphate
Product Name: hydrocortisone sodium phosphate
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: hydrocortisone sodium phosphate
CAS
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients with confirmed Addison’s disease and CAH Aged 18 to 64 years Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active Right handed Able to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Any significant current cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease, renal dysfunction, gastrointestinal emptying or motility disturbances. No current treatment or within the last 3 months of another underlying disease that could necessitate treatment with glucocorticoids Taking of medications that interfere with cortisol metabolism (antiepileptics, St Johns wart, rifampicin) Diagnosis of Addison’s disease less than 6 months ago Pregnant or lactating women Greater than 21 units of alcohol per week Taking of any investigational drug within the past two months Known allergy to any of the study medications and /or materials used in the pump Needle phobia Contraindication to fMRI scan i.e. metal implant/shrapnel Claustrophobia Left handed/ambidextrous Dyslexia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the hormonal responses of patients with Addison's disease and congenital adrenal hyperplasia on standard oral and pulsatile subcutaneous hydrocortisone replacement therapy.;Secondary Objective: To compare the metabolic, psychological (cognitive and emotional processing) and quality of life measures of patients with Addison's disease and congenital adrenal hyperplasia on standard oral replacement and pulsatile subcutaneous hydrocortisone replacement therapy.;Primary end point(s): The primary outcome measure is to achieve a physiological cortisol circadian and ultradian rhythms with adequate suppression of ACTH on waking in both AD and CAH patients, and of morning 17-OHP levels in CAH.;Timepoint(s) of evaluation of this end point: Baseline and 6 week blood samples for ACTH, cortisol and 17-OHP/androstenedione (CAH only) 24 hour blood samples for ACTH, cortisol and cortisone (10 minute all patients), POMC (hourly all patients), 17-OHP (1-3 hourly CAH only) profiles. This is an optional study during week 6-7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective is to be able to demonstrate this intervention improves metabolic parameters, health related quality of life, fatigue, general well being, working memory and emotional and cognitive processing;Timepoint(s) of evaluation of this end point: In each study arm Metabolic parameters - metabolic blood profile (baseline and week 6), weekly body composition, BP and weight. Standardized patient questionnaires for subjective assessment of well-being (main outcome in comparison to baseline) Beck’s inventory of depression scale (baseline only) SF36, Chalder Fatigue Scale, ICFS and AdQuoL (at week -1, 1 and 6) PANAS (at week -1, 1 and 6 ) PSQI (at week -1, 1 and 6 ) and LSEQ (weekly) Ecological Momentary assessment (main outcome, to be collected daily ) Laboratory based psychological tests and fMRI scan (main outcome, week 6) N-Back task (main outcome in comparison to baseline, week 1 and 6) Actigraphy and sleep diary (main outcome, in comparison to baseline and transition of treatment) | — |
Countries
United Kingdom
Contacts
Public ContactStafford Lightman
University of Bristol
Outcome results
None listed