STARLIT-2: Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide - Study 2
Research type
Research Study
Full title
Clinical validation of a non-invasive diagnostic test for adrenal insufficiency using comparative pharmacodynamic equivalence in a healthy population
IRAS ID
1006488
Contact name
Charlotte Elder
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
ISRCTN Number
ISRCTN62724177
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-2 study will be looking to verify that the Nasacthin test does not produce a lower cortisol response compared to the SST.
The study will be performed in healthy men, women and children. 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 four separate occasions, and will receive a different drug at each visit (IV Synacthen, IV placebo, Nasacthin or nasal placebo). The order in which they receive the drugs will be decided randomly before their first visit. Participants will be asked to provide pairs of samples (one blood and one saliva) pre-drug and then at 30, 60, 90 and 120 minutes after the drug is given. Additional saliva samples will be collected by participants at home after 180, 240, 360 and 480 minutes.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0073
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion