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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Charlotte Elder
-
c.j.elder@sheffield.ac.uk


Dr Kathryn Date
+44 (0)1482 464770
kathryn.date@hyms.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A healthy volunteer study to determine the effectiveness of a needle-free test for the diagnosis of adrenal insufficiency
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A healthy volunteer study to determine the effectiveness of a needle-free test for the diagnosis of adrenal insufficiency

Recruiting

Open to: All Genders

Age: Mixed

Sheffield Sheffield

Medical Conditions

Adrenal insufficiency

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The adrenal glands produce cortisol, an essential hormone that 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Dec 2023 20 Apr 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39806610/ (added 20/01/2025)

Participants will attend 4 separate study visits and will receive a different drug at each visit (either nasal tetracosactide (Nasacthin), nasal placebo, IV tetracosactide (Synacthen) or IV 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 sample) at baseline (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, and returned to the study team. All participants will receive a safety telephone call 24-48 hours after each study visit to check for any adverse events.

Participants will also be asked to complete a short paper questionnaire at each of the visits during the 90- and 120-minute sample interval, to explore the acceptability and tolerability of the study drug they received at that visit, and of the associated study procedures. During the final visit, participants will be asked to complete an additional short questionnaire, which will ask about the overall acceptability and tolerability, comparing both the nasal and IV tests.


Healthy men, women and children aged 4-69 years old

You can take part if:



You may not be able to take part if:


Current participant exclusion criteria as of 09/10/2024: 1. Known adrenal insufficiency, Cushing's syndrome or any other adrenal or pituitary gland disorder2. Ongoing pregnancy3. Use of oestrogen-containing hormonal contraception / Hormone Replacement Therapy (due to the effect on cortisol levels)4. Known condition requiring daily administration of a medication that interferes with the metabolism of glucocorticoids, e.g. known to affect corticosteroid binding globulin (CBG), including all oestrogens, or the hypothalamic-pituitary-adrenal (HPA) axis, including opioids, oral antifungals, loperamide5. Currently prescribed anti-epileptic medication, such as sodium valproate, phenytoin, clonazepam, nitrazepam, phenobarbital or primidone6. Known and active protein-losing disorders, e.g. enteropathy or nephrotic syndrome, who may have a cortisol-binding globulin abnormality7. Known clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the ULN).8. Participants on regular, inhaled, topical, nasal, ocular, rectal, oral or intra-articular steroids for any indication in the last 3 months9. Current uncontrolled active infection10. BMI >35 kg/m² (or BMI >3 standard deviations (SD) above the mean for age and sex if <16 years)11. Known or suspected alcohol dependence or drug misuse12. Current smoker or vaper (or within 6 months of cessation)13. Recent (within 1 week) liquorice ingestion (preparations containing glycyrrhizic acid only)14. Individuals with a history of known salivary gland or oral mucosa pathology who are unable to produce a suitable salivary sample (e.g. as a consequence of drugs that cause dry mouth)15. Previous severe allergic reaction or anaphylaxis or adverse reaction to any antigen of ACTH or Synacthen16. Participation in another clinical trial of an investigational or licensed drug within the 3 months prior to inclusion in study, unless it is a clinical trial of the same IMP (i.e. Nasacthin), in which case only a 7-day washout period applies17. Participants unable to comply with the requirements of the protocol18. Participants with any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial19. For nasal visits only: coryzal symptoms within the last week (and will be asked to report any new symptoms occurring within 24 hours of the test) or heavy nosebleed within the previous 48 hours - just excluded from that visit

Previous participant exclusion criteria:1. Known adrenal insufficiency, Cushing's syndrome or any other adrenal or pituitary gland disorder2. Ongoing pregnancy3. Use of oestrogen-containing hormonal contraception / Hormone Replacement Therapy (due to the effect on cortisol levels)4. Known condition requiring daily administration of a medication that interferes with the metabolism of glucocorticoids, e.g. known to affect corticosteroid binding globulin (CBG), including all oestrogens, or the hypothalamic-pituitary-adrenal (HPA) axis, including opioids, oral antifungals, loperamide5. Known and active protein-losing disorders, e.g. enteropathy or nephrotic syndrome, who may have a cortisol-binding globulin abnormality6. Known clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the ULN).7. Participants on regular, inhaled, topical, nasal, ocular, rectal, oral or intra-articular steroids for any indication in the last 3 months8. Current uncontrolled active infection9. BMI >35 kg/m² (or BMI >3 standard deviations (SD) above the mean for age and sex if <16 years)10. Known or suspected alcohol dependence or drug misuse11. Current smoker or vaper (or within 6 months of cessation)12. Recent (within 1 week) liquorice ingestion (preparations containing glycyrrhizic acid only)13. Individuals with a history of known salivary gland or oral mucosa pathology who are unable to produce a suitable salivary sample (e.g. as a consequence of drugs that cause dry mouth)14. Previous severe allergic reaction or anaphylaxis or adverse reaction to any antigen of ACTH or Synacthen15. Participation in another clinical trial of an investigational or licensed drug within the 3 months prior to inclusion in study16. Participants unable to comply with the requirements of the protocol17. Participants with any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial18. For nasal visits only: coryzal symptoms within the last week (and will be asked to report any new symptoms occurring within 24 hours of the test)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Sheffield Childrens Hospital
    Western Bank
    Sheffield
    S10 2TH

While there will be no direct benefit to participants, the study will be an important step in the development of the test towards its routine use in the NHS, which would ultimately benefit patients being investigated for AI in the future.
Participants must have a cannula inserted at each visit for IV drugs to be given and for blood sampling, which may be briefly painful or can rarely cause slight bruising or local swelling. Synacthen and Nasacthin do not cause any long-term side effects, but mild and short-lived effects such as watery eyes, sneezing, coughing or a vinegary taste may be experienced after the nasal spray, and with both drugs, there is also a very small risk of a potentially severe allergic reaction.
There is also a very small chance that the sample results might show lower-than-normal levels of cortisol in response to the drugs, which would require further investigation via the standard care pathway.

Dr Charlotte Elder
-
c.j.elder@sheffield.ac.uk


Dr Kathryn Date
+44 (0)1482 464770
kathryn.date@hyms.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Sheffield Children's NHS Foundation Trust and funded by Medical Research Council.



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Read full details for Trial ID: ISRCTN62724177

Or CPMS 55547

Last updated 10 March 2025

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