Adrenal insufficency Nutritional, Metabolic, Endocrine
Conditions
Interventions
Part A: 10 non-pregnant adult participants with primary adrenal insufficiency will attend the Newcastle clinical research facility fasted, first thing in the morning (e.g., 08:00 hours), having omitt
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with primary adrenal insufficiency (owing to Addison’s disease or bilateral adrenalectomy) 2. Age over 18 years 3. Ability to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Not pregnant, breastfeeding or with a plan for pregnancy within 1 month 2. No known residual adrenal function, documented poor medication concordance or persistent pigmentation, concomitant type 1 diabetes (for Parts A + B only) 3. No significant lung disease that could impair the absorption of fluticasone 4. No active ischaemic heart disease, cerebrovascular disease or other condition that, in the opinion of the principal investigator, would render the temporary suspension of steroid hormone unsafe 5. No dementia, active psychotic or serious mental health condition 6. No current use of steroid inhaler or other medication that could interfere with the interpretation of plasma ACTH, including opiates, non-replacement steroids (e.g., topical or depot), ritonavir, other potent CYP3A4 inhibitors 7. No known allergy or anaphylaxis to fluticasone or any other component of the investigative product 8. Not participating in another CTIMP study, currently or within the prior 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Plasma ACTH measured using immunoassay at 10, 20, 30, 45, 60, 90 min following inhaled fluticasone vs IM hydrocortisone bolus Part B: Serum fluticasone levels measured using mass spectrometry at 10, 20, 30, 60 min following inhaled fluticasone in participants with drug-induced nausea/vomiting Part C: Utilisation of fluticasone in real-life situations measured using diary analysis and narrative review at end of study; 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: 1. Serum fluticasone and/or cortisol levels measured using mass spectrometry and immunoassay, respectively, at 10, 20, 30, 60 min following inhaled fluticasone or IM hydrocortisone bolus 2. Biochemical analysis of stress markers: prolactin, copeptin, IL6, TNFa, GDF15, miRNA122-5b measured using immunoassay at 10, 20, 30, 60 minutes 3. Patient health state assessed using visual analogue scales at 20, 40, 60 and 90 minutes 4. Qualitative patient feedback on experience using interview at end of study 5. Vital signs measured using dynamap at 10, 20, 30 and 60 minutes Part B: 1. Patient health state assessed using visual analogue scales at 20, 40, 60 and 90 minutes 2. Qualitative patient feedback on experience using interview at end of study 3. Vital signs measured using dynamap at 10, 20, 30 and 60 minutes Part C: 1. Patient-reported wellbeing outcome(s) measured using WHO-5, AddiQoL and EQ-5D at end of study (6 months) 2. Patient-reported acceptability of inhaled steroid measured using Treatment Satisfaction Questionnaire for Medication (TSQM) at end of study (6 months) 3. Blood pressure, BMI and serum HbA1c measured using SECA scale, dynamap and immunoassay, respectively, at end of study (6 months) | — |
Countries
England, United Kingdom
Outcome results
None listed