A patient study to determine the effectiveness of a needle-free test for the diagnosis of adrenal insufficiency

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 32

Inclusion Criteria

1. Known adrenal insufficiency
2. Basal cortisol <100 nmol/L or peak on SST <200 nmol/L at time of diagnosis or since in last 6 months
3. Able to comply with passive drool salivary sampling requirements
4. Able to provide signed written informed consent
5. Age 4-75 years

Exclusion Criteria

1. Ongoing pregnancy
2. Use of oestrogen-containing hormonal contraception / Hormone Replacement Therapy (due to the effect on cortisol levels)
3. Co-morbid condition requiring daily administration of a medication that interferes with the metabolism of glucocorticoids, e.g. known to affect corticosteroid-binding globulin (CBG), including all oestrogens, or the hypothalamic-pituitary-adrenal (HPA) axis, such as loperamide, oral antifungals and opiates
4. Known and active protein losing disorder, e.g. enteropathy or nephrotic syndrome, which may result in a cortisol binding globulin abnormality
5. Known clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the ULN
6. Current uncontrolled active infection (may include later in the trial at clinician's discretion if completely resolved)
7. Known or suspected alcohol dependence or drug misuse
8. Current smoker or vaper (or within 6 months of cessation)
9. Recent (within last 1 week) liquorice ingestion (preparations containing glycyrrhizic acid only)
10. History of known salivary gland or oral mucosa pathology or unable to produce a suitable salivary sample (e.g. as a consequence of drugs that cause dry mouth)
11. Previous severe allergic reaction or anaphylaxis, or adverse reaction to any antigen of ACTH or Synacthen
12. Participation in another clinical trial of an investigational or licensed drug or device within the last 3 months
13. Unable to comply with the requirements of the protocol
14. Any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial
15. For nasal visit only - Coryzal symptoms within the last week - just excluded from that visit

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants with adrenal insufficiency (AI) diagnosed by the Nasacthin Test (Positive Percent Agreement) using serum cortisol at baseline and 30 minutes post-drug administration, measured using liquid chromatography with tandem mass spectrometry (LC-MS/MS). To be included in the analysis, participants will have been confirmed to have AI by assessment of serum cortisol at 30 minutes following the Synacthen test.

Secondary Outcome Measures

Name	Time	Method
1.Frequency of adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) by treatment arm, as reported by participants up to 48 hours after each study visit. Any SAEs/SUSARs will be followed to the point of resolution.<br>2.Analysis of participant and healthcare professional acceptability, usability and tolerability of the Nasacthin test, measured using non-validated questionnaires completed by participants at the end of each study visit and by healthcare professionals at the end of the study; and optional participant and stakeholder focus groups held at the end of the study.