STARLIT-3: Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide - Study 3
Research type
Research Study
Full title
Clinical Validation of a Non-Invasive Diagnostic Test for Adrenal Insufficiency using Comparative Pharmacodynamic Equivalence in a Patient Population Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide - Study 3 (STARLIT-3)
IRAS ID
1009462
Contact name
Charlotte Elder
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
ISRCTN Number
ISRCTN26461337
Research summary
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 with replacement cortisol, can lead to serious illness and death. The Short Synacthen Test (SST) is the most popular diagnostic test for AI worldwide. Synacthen (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. It is thus invasive, requires trained staff to deliver the test, and is unpleasant for the patient, especially children. A non-invasive, needle-free alternative to the SST has been developed, the Nasacthin test, with the tetracosactide given nasally via a spray and the resultant cortisol and cortisone (the salivary equivalent to cortisol) response measured in saliva samples. The STARLIT-3 study will be looking to compare if the Nasacthin test is as good as the SST at diagnosing AI.
The study will be performed in men, women and children living with AI. Study visits will take place across two Clinical Research Facilities (CRFs), the Royal Hallamshire Hospital for adult participants and Sheffield Children's Hospital for children and young people. Participants will attend on two separate occasions, and will receive a different study drug at each visit (either IV Synacthen or Nasacthin). The order in which they receive the drugs will be decided randomly before the first visit. Participants will be asked to provide pairs of samples (one blood and one saliva) pre-drug and then at 30 and 60 minutes after the drug is given. Participants will also be asked to complete a short questionnaire during each visit about their experience of having the test.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0102
Date of REC Opinion
20 May 2024
REC opinion
Further Information Favourable Opinion