Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03514589
PHASE2

NeSST2: The Development of a Noninvasive Short Synacthen Test

Sponsor: Sheffield Children's NHS Foundation Trust

View on ClinicalTrials.gov

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 longterm 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 noninvasive alternative to the current SST, with Synacthen given nasally and using saliva to measure the subsequent production of cortisol. A noninvasive test will allow us to establish the first normal ranges for children and determine which children with asthma are at risk of adrenal suppression.

Official title: NeSST2: A Multi-stage Clinical Study to Develop a Non-invasive Short Synacthen Test (SST)

Key Details

Gender

MALE

Age Range

6 Months - 60 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2012-10-12

Completion Date

2025-12-01

Last Updated

2024-12-03

Healthy Volunteers

Yes

Interventions

DRUG

nasal Tetracosactide

Bioavailability of nasal synacthen compared to IV comparator

DRUG

IV tetracosactide

Bioavailability of nasal synacthen compared to IV comparator

Locations (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom