NeSST2: The Development of a Noninvasive Short Synacthen Test

Short name NeSST2

NCTNCT03514589Other idSCH/12/043

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 2
Enrollment: 12 participants (estimated)
Sponsor: Sheffield Children's NHS Foundation Trust · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United Kingdom
Start: 12 Oct 2012
Primary completion: 1 Dec 2025 (estimated)
Completion: 1 Dec 2025 (estimated)
First posted: 2 May 2018
Last update posted: 3 Dec 2024
Conditions: Adrenal Suppression

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520202025

Ph 2
NeSST2
NCT03514589
12 Oct 2012 to est. 1 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

nasal TetracosactideDrug
IV tetracosactideDrug

Arms2

Active comparator
Arm 1
250 mcg IV synacthen
Experimental
Arm 2
Nasal Synacthen

Primary outcomes5

Outcomes the sponsor listed as primary.

Peak plasma cortisol concentration (Cmax)
Time frame · 6 months
Registry description
Peak plasma cortisol following synacthen
Time of peak plasma cortisol concentration (Tmax)
Time frame · 6 months
Registry description
Time of Cmax
Bioavailability of nasal Synacthen (compared to IV Synacthen)
Time frame · 6 months
Registry description
Proportion of synacthen measurable in blood following administration (IV or nasal) and so is able to have an active effect.
Area under the curve for plasma Synacthen (nasal compared to IV)
Time frame · 6 months
Registry description
Total exposure to synacthen
Area under the curve for plasma cortisol (nasal compared to IV)
Time frame · 6 months
Registry description
Total exposure to plasma cortisol following synacthen

Secondary outcomes(2)

Tolerability and acceptability of nasal Synacthen test
Time frame · Course of the study (2.5 years)
Registry description
Questionnaire answers to questions on tolerability and acceptability of nasal Synacthen test. Safety data
Correlation of plasma cortisol with salivary cortisol
Time frame · 6 months
Registry description
relationship of peak plasma cortisol and peak salivary cortisol

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 6 Months up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: Stage 1b+c: • Healthy, male volunteers aged between 18-64 with none of the exclusion criteria listed below. Stage 2: • Healthy children of either sex, aged between 2 and 15 years (up to their 16th birthday) with none of the exclusion criteria listed below. Stage 3: • Healthy children of both sexes, aged between 0-18 years without exclusion criteria 1,2,3,5,6,7,8,9,10,11,12,14 listed below. Stage 4: • Asthmatic children of both sexes, aged between 6 months and 15 years, prescribed regular inhaled corticosteroids and without exclusion criteria 1,5,9,10,11,12, and 14 listed below. Exclusion Criteria: 1. Past or present history of an endocrinopathy (all stages) 2. Past or present history of asthma (stages 1b+c,2,3) 3. Past or present history of allergic rhinitis (stages 1b+c,2,3) 4. Past or present history of peptic ulcer disease/GI bleed/significant dyspepsia (stages 1b+c,2) 5. Past history of intra-cranial or renal/adrenal pathology (all stages) 6. Presently on any medication (stages 1b+c,2,3) 7. Presently, or within the last 3 months, been prescribed any type of corticosteroid (oral, inhaled, nasal, rectal, intravenous, intramuscular, intra-articular, intra-ocular, topical) (stages 1b+c,2,3) 8. Ever been prescribed a prolonged course of oral corticosteroids (more than 1 month) (stages 1b+c,2,3) 9. Previous adverse reaction (including mild hypersensitivity) to ACTH or Synacthen (all stages) 10. Previous severe allergic reaction or anaphylaxis (all stages) 11. Coryzal symptoms within the last week (and will be asked to report any new symptoms occurring within 24 hours of the test) (all stages) 12. Current smoker (all stages) 13. Body Mass Index less than 18.5 or more than 30kg/m2 (stages 1b+c) outside 3rd to 97th centiles for ages and sex (stage 2) 14. Currently pregnant (stages 2,3,4) 15. Currently anaemic (stages 1b+c,2)

PepBank is a research reference. Talk to a doctor before you use any peptide.