NeSST2: The Development of a Noninvasive Short Synacthen Test

Launched by SHEFFIELD CHILDREN'S NHS FOUNDATION TRUST · Apr 20, 2018

Keywords

ClinConnect Summary

The NeSST2 clinical trial is investigating a new, easier way to check how well the body’s adrenal glands produce cortisol, a vital stress hormone. This is particularly important for children who use inhaled steroids for asthma, as these medications can sometimes lead to a condition called adrenal suppression, where the body doesn't make enough cortisol during times of stress. The trial aims to replace the current, invasive Short Synacthen Test (which requires a needle and blood samples) with a noninvasive method that uses a nasal spray and saliva, making it much more comfortable for children.

To participate in the trial, healthy males aged 18-64 and children aged 0-15 (who are healthy or have asthma) may be eligible, provided they meet specific health criteria. Participants can expect to take the nasal spray and provide saliva samples to help researchers understand how inhaled steroids affect cortisol production. This study is crucial for developing safer asthma treatments and ensuring that children are properly monitored for any potential health risks related to steroid use.

Gender

MALE

Eligibility criteria

• 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)