Actively Recruiting

Phase 2
Age: 6Months - 60Years
MALE
Healthy Volunteers
NCT03514589

NeSST2: The Development of a Noninvasive Short Synacthen Test

Led by Sheffield Children's NHS Foundation Trust · Updated on 2024-12-03

12

Participants Needed

1

Research Sites

685 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NeSST2: The Development of a Noninvasive Short Synacthen Test

Who Can Participate

Age: 6Months - 60Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy, male volunteers aged 18 to 64 years without exclusion criteria
  • Healthy children of either sex aged 2 to 15 years without exclusion criteria
  • Healthy children of both sexes aged 0 to 18 years without certain exclusion criteria
  • Asthmatic children of both sexes aged 6 months to 15 years on regular inhaled corticosteroids without certain exclusion criteria
Not Eligible

You will not qualify if you...

  • Any past or present history of endocrinopathy
  • Past or present history of asthma (for stages 1b+c, 2, and 3)
  • Past or present history of allergic rhinitis (for stages 1b+c, 2, and 3)
  • Past or present history of peptic ulcer disease, gastrointestinal bleed, or significant dyspepsia (for stages 1b+c and 2)
  • Past history of intracranial or renal/adrenal pathology
  • Currently on any medication (for stages 1b+c, 2, and 3)
  • Use of corticosteroids in the last 3 months (oral, inhaled, nasal, rectal, intravenous, intramuscular, intra-articular, intra-ocular, topical) for stages 1b+c, 2, and 3
  • Ever prescribed a prolonged course of oral corticosteroids (more than 1 month) for stages 1b+c and 2
  • Previous adverse reaction to ACTH or Synacthen
  • Previous severe allergic reaction or anaphylaxis
  • Coryzal symptoms within the last week or new symptoms within 24 hours of testing
  • Current smoker
  • Body mass index less than 18.5 or more than 30 kg/m2 (for stages 1b+c) or outside 3rd to 97th centiles for age and sex (stage 2)
  • Currently pregnant (for stages 2, 3, and 4)
  • Currently anaemic (for stages 1b+c and 2)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH

Actively Recruiting

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Research Team

M

Meena Balasubramanian

CONTACT

G

Gillian Gatenby

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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