NeSST2: The development of a non-invasive Short Synacthen Test

• Research type

  Research Study

• Full title

  NeSST2: A multi-stage clinical study to develop a non-invasive Short Synacthen Test (SST) with nasally administered Synacthen and salivary cortisol. The validated non-invasive SST will be used to establish normative data in children and to detect adrenal suppression in asthmatic children.

• IRAS ID

  111633

• Contact name

  Charlotte Elder

• Sponsor organisation

  Sheffield Children's NHS Foundation Trust

• Eudract number

  2012-003241-15

• ISRCTN Number

  n/a

• Research summary

  Recently there has been concern about the effect of inhaled steroids, routinely used in the treatment of asthma, on the body's ability to produce its natural stress hormone - cortisol. Failure of adequate cortisol production in times of stress e.g. illness, can result in serious illness or death. Patients receiving long-term steroid treatment may have reduced levels of cortisol and not be able to produce adequate amounts in times of need, a process called adrenal suppression. Initially it was thought that the absorption of inhaled steroids into the bloodstream would be too low to cause adrenal suppression however high profile deaths followed by a national survey revealed a number of fatal or near fatal cases of adrenal suppression. The vast majority of these were in children. Since then doctors have been encouraged to ensure that children on high doses of inhaled steroids carry a steroid alert card and that the ability of their adrenal glands to produce adequate amounts of cortisol is checked. However it is unknown what dose of inhaled steroids puts one at risk, whether age or gender affects one's risk and when to check the function of the adrenal gland. The Short Synacthen Test (SST) investigates the ability of the body's adrenal glands to produce cortisol. Presently the SST requires intravenous (i.v) cannulation through which Synacthen is injected to stimulate the adrenal glands and multiple blood samples are collected to assess the response in terms of cortisol production. It is invasive, time consuming and unpleasant for the child. Our project aims to produce a non-invasive alternative to the current SST, with Synacthen given nasally and using saliva to measure the subsequent production of cortisol. A non-invasive test will allow us to establish the first normal ranges for children and determine which children with asthma are at risk of adrenal suppression.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/1411

• Date of REC Opinion

  9 Oct 2012

• REC opinion

  Favourable Opinion