Noninvasive test for adrenal function in children and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: meena.balasubramanian@nhs.net

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.