Skip to main content

Research Repository

Advanced Search

STARLIT: Clinical validation of a non-invasive diagnostic test for adrenal insufficiency using comparative pharmacodynamic equivalence

People Involved

Project Description

The STARLIT (Salivary Test for Adrenal Response to Liquid Intranasal Tetracosactide) programme is funded by the MRC DPFS, total award £986,123.

The aim is to develop and clinically validate the Nasacthin test for the diagnosis of adrenal insufficiency, detailed information can be found on the study website https://hhtu.hull.ac.uk/starlit/

The adrenal glands produce cortisol, an essential hormone which is released as part of the body’s stress response and helps to control blood pressure and blood sugar levels. Adrenal insufficiency (AI) describes the inability of the body to produce adequate levels of cortisol which, without treatment and replacement cortisol, can lead to serious illness and death. The Short Synacthen Test (SST) is the most popular diagnostic test for AI worldwide. Synacthen (also known as tetracosactide) is a drug which stimulates the adrenal glands to produce cortisol. The SST requires intravenous cannulation and blood sampling before and after the Synacthen is given. A non-invasive, needle-free alternative to the SST has been developed, the Nasacthin test, with the tetracosactide is given nasally via a spray and the resultant cortisol and cortisone (the salivary equivalent to cortisol) response measured in saliva samples.

Three studies are being conducted as part of STARLIT:
STARLIT-1: Reproducibility study to compare blood and saliva cortisol and cortisone levels within the same individual in healthy adults.
STARLIT-2: Healthy volunteer study - randomised, placebo-controlled, double-blinded, 4-way crossover trial to compare the blood sample test (Synacthen) to the needle-free test (Nasacthin).
STARLIT-3: Clinical validation study - randomised, 2-way crossover pharmacodynamic study to evaluate the diagnostic performance of the needle-free test (Nasacthin) compared to blood sample test (Synacthen) in patients with AI.

Study team:
CI, Charlotte Elder, University of Sheffield
CTU, Hull Health Trials Unit
Research Governance Sponsor, Sheffield Childrens Hospital NHS Trust

Type of Project Clinical Trial
Project Acronym NaTChAS
Status Project Live
Funder(s) Medical Research Council
Value £293,574.00
Project Dates Sep 1, 2022 - Dec 31, 2025

You might also like

LIPS: A prospective registry-based cohort study to monitor the diagnosis and management of acute leukaemia in pregnancy Jun 1, 2018 - Feb 28, 2022
Acute leukaemia (AL) is an aggressive but potentially curable cancer that can affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother’s survival through... Read More about LIPS: A prospective registry-based cohort study to monitor the diagnosis and management of acute leukaemia in pregnancy.

Organic Disease masquerading as IBS: an RCT in primary care: The Lincolnshire Poacher Study (Promoting Optimal Assessment to Change Health and Engineer an Economic Revolution Jun 1, 2020 - Apr 30, 2023
Irritable bowel syndrome (IBS) affects up to 1 in 5 people in Britain. IBS can have a huge impact on a sufferer’s daily activities, general wellbeing, and overall health. IBS often carries major financial implications because of time lost from work,... Read More about Organic Disease masquerading as IBS: an RCT in primary care: The Lincolnshire Poacher Study (Promoting Optimal Assessment to Change Health and Engineer an Economic Revolution.