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: 9.0 Level: PT Classification code 10001367 Term: Adrenal Insufficiency MedDRA version: 9.0 Level: PT Classification
Conditions
Interventions
Trade Name: Synacthen
Product Name: Synacthen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tetracosactide
CAS Number: 16960-16-0
Other descriptive name: Cosyntropin (USAN)
Concentr
Sponsors
Sheffield Children's NHS Foundation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Stage 1a: To establish the bioequivalence of nasal synacthen with 1 microgram of intravenous synacthen in adult volunteers. To determine the bioavailability and pharmacokinetics of nasally administered synacthen and the subsequent peak cortisol response. To determine the inter-individual variability of nasally administered synacthen. Stage 1b: To determine the intra-individual variability of nasally administered synacthen Stage 2: To establish whether the peak cortisol response, bioavailability and pharmacokinetics are similar in the paediatric population to that of adult males. Stage 3: To establish the first normative data for the Short Synacthen Test in healthy children. Stage 4: To establish which children on inhaled corticosteroids are at greatest risk of adrenal suppression.;Primary end point(s): A validated non-invasive test of adrenal function (stages 1+2). Normative data for the low-dose short synacthen test in children (stage 3). The dose of inhaled corticosteroids that causes adrenal suppression in children (stage 4).;Main Objective: To establish whether nasally administered synacthen, combined with salivary cortisol sampling, can be used effectively to investigate potential adrenal suppression and therefore be a valid non-invasive alternative to the current, intravenous low-dose Short Synacthen Test. | — |
Countries
United Kingdom
Outcome results
None listed