Noninvasive test for adrenal function in children and adults

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

This study is testing a new noninvasive way to check how well the adrenal glands are working in children and adults who use inhaled steroids, to see if it’s safer and easier than the traditional method.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 6 Months to 60 Years
• Sex: Male
• Sponsor: Sheffield Children's NHS Foundation Trust (other)
• Locations: 1 site (Sheffield, Sheffield (South Yorkshire District))
• Trial ID: NCT03514589 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to develop a noninvasive Short Synacthen Test (SST) to assess adrenal function in individuals, particularly focusing on children who are prescribed inhaled corticosteroids. The study will evaluate the pharmacokinetics of nasal Tetracosactide in both healthy adults and children, comparing it to the traditional intravenous method. By conducting this research, the trial seeks to establish a safer and more practical method for monitoring adrenal suppression, which can occur due to long-term steroid use. The trial will involve multiple visits to a specialized children's clinical research facility to gather necessary data.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-64 and children aged 0-15 years who are prescribed inhaled corticosteroids.

Not a fit: Patients with a history of endocrinopathy or those currently suffering from asthma or allergic rhinitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer, noninvasive method for monitoring adrenal function in patients using inhaled corticosteroids.

How similar studies have performed: While the approach of using a noninvasive method for adrenal function testing is innovative, similar studies have shown promise in assessing adrenal suppression in other contexts.

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)

Where this trial is running

Sheffield, Sheffield (South Yorkshire District)

• Sheffield Children's NHS Foundation Trust — Sheffield, Sheffield (South Yorkshire District), United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Charlotte Elder — Investigator
• Study coordinator: Meena Balasubramanian

Conditions: Adrenal Suppression