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Endocrine Abstracts (2018) 59 OC4.3 | DOI: 10.1530/endoabs.59.OC4.3

SFEBES2018 Oral Communications Clinical highlights (6 abstracts)

A novel non-invasive short synacthen test validated in healthy adult and paediatric populations

Charlotte Elder 1, , Ruben Vilela 2 , Alexandra Cross 2 , Trevor Johnson 3 , E Helen Kemp 2 , Brian Keevil 4 , Jerry Wales 5 , John Newell-Price 6 , Richard Ross 2 & Neil Wright 1


1Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 2The Univeristy of Sheffield, Sheffield, UK; 3Simcyp Ltd, Sheffield, UK; 4University of Manchester, Manchester, UK; 5University of Queensland, Brisbane, Australia; 6The Univeristy of Sheffield, Sheffield, UK.


Introduction: Worldwide the Short Synacthen Test (SST) is the most popular investigation for adrenal insufficiency (AI). Its invasivity make it resource-intensive. Salivary cortisol is a well-established alternative to serum. We have developed a non-invasive alternative to the SST, using a novel formulation of Synacthen (containing a drug enhancer, chitosan) administered nasally and utilising saliva to measure glucocorticoid response.

Methods: Four open-label, sequence-randomised, cross-over pharmacokinetic studies and a repeatability study were conducted in dexamethasone suppressed participants. Twelve healthy adult males were recruited to each study, 6 re-recruited for the repeatability study and 24 children (12F) aged 4–14 years participated in the paediatric study. The intravenous comparator was 250mcg or 1mcg synacthen. Nasal formulations were administered using a mucosal atomiser device. Fourteen paired blood and saliva samples were taken and measurements of plasma Synacthen (ACTH EIA), serum cortisol (chemiluminescent immunoassay) and salivary cortisol and cortisone (LC-MS/MS) made.

Results: The addition of chitosan and dose escalation improved bioavailability and cortisol response. The Nasacthin003 formulation was selected based on superior bioavailability and serum cortisol responses. Administration of nasal synacthen was highly reproducible. The mean plasma cortisol Cmax in children compared with adults was 568 nmol/L (±79) versus 558 (±110), 406 (±77) versus 400 (±89) and 630 (±54) versus 615 (±51) for Nasacthin003, 1mcg IV and 250 mcg IV respectively. Salivary cortisol and cortisone samples were closely correlated with their paired serum samples (r=0.88 and 0.90 respectively). Salivary cortisone was the more sensitive marker of adrenocortical response at lower serum cortisol values. Nasal Synacthen was well tolerated with no unexpected adverse events.

Conclusions: We have validated a non-invasive SST, with PK parameters demonstrating Nasacthin003 stimulation leading to an indistinguishable glucocorticoid response in both serum and saliva compared to high and low-dose IV synacthen in adults and children.

Volume 59

Society for Endocrinology BES 2018

Glasgow, UK
19 Nov 2018 - 21 Nov 2018

Society for Endocrinology 

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