A multi-stage clinical study to develop a non-invasive Short Synacthen Test (SST) with nasally administered synacthen and salivary cortisol. The validated non-invasive SST will be used to establish normative data in children and to detect adrenal suppression in asthmatic children. - The development of a non-invasive Short Synacthen Test - NeSST Study

Phase 1

• Conditions: In stages 1+2 of the study healthy volunteers will be used to determine the bioequivalence of nasal synacthen with 1 microgram of intravenous synacthen. Stage 3 will use healthy children to establish normal ranges for the adrenal response to a low-dose synacthen test. In stage 4 adrenal function in asthmatic individuals on inhaled corticosteroids will be studied.; MedDRA version: 9.0Level: PTClassification code 10001367Term: Adrenal Insufficiency; MedDRA version: 9.0Level: PTClassification code 10006482Term: Bronchospasm

• Registration Number: EUCTR2009-013355-29-GB
• Lead Sponsor: Sheffield Children's NHS Foundation Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Stage 1(a+b): Healthy, male volunteers aged 18-64, with no exclusion criteria listed below.

Stage 2: Healthy children of either sex, aged between 2 years and 15 years, with no exclusion criteria listed below.

Stage 3: Healthy children of both sexes, aged between 6 months and 15 years, without exclusion criteria 1,2,3,5,6,7,8,9,10,11,12 and 14 listed below.

Phase 4: Children of both sexes, aged between 6 months and 15 years, prescribed varying doses of regular inhaled corticosteroids and without exclusion criteria 1,5,9,10,11,12 and 14 as listed below.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Past or present history of an endocrinopathy.
2. Past or present history of asthma.
3. Past or present history of allergic rhinitis
4. Past or present history of peptic ulcer disease/GI bleed/significant dyspepsia.
5. Past history of intra-cranial, renal or adrenal pathology.
6. Presently on any prescribed medication.
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).
8. Ever been prescribed a prolonged course (more than 1 month) of oral steroids.
9. Previous serious allergic reaction or an episode of anaphylaxis.
10. Previous adverse reaction (including mild hypersensitivity)to ACTH or synacthen.
11. Coryzal symptoms within the last week.
12. Current smoker.
13. Body Mass Index more than 30.
14. Currently pregnant
15. Currently anaemic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified