STARLIT 2

Study Design: CTIMP
Disease Area: Endocrinology
Funder: Medical Research Council
Sponsor: Sheffield Children’s NHS Foundation Trust
Chief Investigator: Dr Charlotte Elder

Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide

STARLIT 2

RECRUITING

Summary

Adrenal insufficiency (AI) is the medical term for the body’s adrenal glands not producing enough of the vital stress hormone, cortisol. This can lead to a life-threatening situation called an adrenal crisis if left untreated. Cortisol is usually measured in blood samples, but we are developing ways to diagnose adrenal insufficiency by measuring cortisol (and a very similar hormone, cortisone) in saliva samples, which will lead to needle-free testing.

The test where blood samples are taken looks to see if the adrenal glands can or cannot react to stress. A drug called Synacthen (also known as tetracosactide is given via a needle and this mimics the body’s natural response to stress by stimulating the production of cortisol, as your body would do normally.

Our new needle-free test uses a drug called Nasacthin. Nasacthin is the same as the Synacthen drug, except it has another substance added to it to help it to be absorbed from the nose into the blood. It is given via a nasal spray, but works in the same way as Synacthen to stimulate cortisol production.

What we plan to do

We will recruit a total of 32 healthy volunteers, and will look to see if our new needle-free test, where you receive a drug (Nasacthin) via a nasal spray and measure cortisol levels in saliva, gives comparable results to the standard test (Short Synacthen Test), where drug is given using a needle and cortisol is measured in blood samples.

Chief Investigator

Charlotte Elder - University of Sheffield

HHTU Study team

Kathryn Date - Trial Manager
Amy Bromby - Trial Co-ordinator
Judith Cohen - Co-Investigator, HHTU Director
Bronwen Williams - Operations Manager
John Turgoose - Information Systems Manager
Sarah Sumpter - Senior Data Manager
Phillip Best - Data Manager
Kerri Morris - Trial Administrator
Paul Bradley - Unblinded Trial Monitor

Collaborators

Richard Ross - Co-Investigator - University of Sheffield
Simon Dixon - Co-Investigator - University of Sheffield
Miguel Debono - Co-Investigator - Sheffield Teaching Hospitals
Sharon Caunt - PPI Lead / Qualitative researcher - Sheffield Teaching Hospitals
Keith Pugh  - Sponsor Representative - Sheffield Childrens Hospital
Kathleen Baster - Statistician - University of Sheffield 
Nicola Galley - Commercialisation Manager - University of Sheffield 
Evy De Leenheer - Project Manager - University of Sheffield 
Peter Watts - Phormulate Consulting
Trevor Johnson - PKPD modelling expert

Email address

starlit.2and3@hyms.ac.uk

Participating Sites 

  • Sheffield Children’s Hospital (Sheffield Children’s NHS Foundation Trust)
  • Royal Hallamshire Hospital (Sheffield Teaching Hospitals NHS Foundation Trust)

To find out more about the study you can read your relevant STARLIT 2 Participant Information Leaflet below.

Participant Information Leaflet for Adults
Participant Information Leaflet for Parents / Legal Guardians
Participant Information Leaflet for Children aged 5-9 years
Participant Information Leaflet for Young People aged 10-15 years
Participant Information Leaflet Easy Read

Click on the relevant privacy notice below for the STARLIT 2.
Privacy Notice for Adults
Privacy Notice for Children

Please click on the links below to find out more.

What is it like to take part in a clinical trial?

How can I take part in research?

Videos provided by Sheffield Children's Hospital Trust.