EUCTR2009-013355-29-GB
Active, not recruiting
Phase 1
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
Sheffield Children's NHS Foundation Hospital0 sites258 target enrollmentJune 24, 2010
ConditionsIn 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 InsufficiencyMedDRA version: 9.0Level: PTClassification code 10006482Term: Bronchospasm
DrugsSynacthen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Sheffield Children's NHS Foundation Hospital
- Enrollment
- 258
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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