Method of diagnosis of adrenal insufficiency
AssigneesSheffield Children's NHS Foundation Trust, The University of Sheffield
InventorsNeil Peter Wright, Charlotte Jane Elder
Life of this patent
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Abstract
The disclosure relates to a composition comprising adrenocorticotropic hormone (ACTH) or a synthetic ACTH analogue for use in a diagnostic test for adrenal insufficiency. A method to conduct said diagnostic test; a combined diagnostic and method of treatment; and kits comprising the components for said test are also disclosed.
Claims15
A method of diagnosing adrenal insufficiency in a paediatric subject, comprising:
- i) obtaining a sample of saliva from the paediatric subject and measuring cortisone concentration in said saliva sample;
- ii) intranasally administering a pharmaceutical composition to the paediatric subject at a dose of between 500-1000 μg, the composition comprising:
- tetracosactide acetate 0.25% (w/v);
- chitosan glutamate 0.5% (w/v);
- sodium chloride 0.54% (w/v);
- benzalkonium chloride 0.015% (w/v);
- acetic acid 0.51% (w/v);
- and
- sodium acetate trihydrate 0.21% (w/v);
- and
- iii) repeating step i) 120 minutes or 180 minutes after the intranasal administration of step ii).
A method of diagnosis of adrenal insufficiency in a neonate subject between 0-28 days old or an infant subject between 1 to 12 months old, comprising:
- i) obtaining a sample of saliva from the neonate or infant subject and measuring cortisone concentration in said saliva sample;
- ii) intranasally administering a pharmaceutical composition adapted for nasal administration comprising an effective dose of tetracosactide acetate, chitosan glutamate, and an acid, wherein said composition has a viscosity of between 10 to 300 mPAs;
- iii) repeating step i);
- iv) comparing the concentration of cortisone in the saliva sample of step (i) with the cortisone concentration of step (iii);
- and
- v) identifying adrenal insufficiency in the neonate or infant subject.
A method of diagnosis of adrenal insufficiency in a neonate subject between 0-28 days old or an infant subject between 1 to 12 months old, comprising:
- i) obtaining a saliva sample from the neonate or infant subject and measuring cortisone concentration in the saliva sample;
- ii) intranasally administering a pharmaceutical composition to the neonate or infant subject at a dose of between 500-1000 μg, wherein the pharmaceutical composition comprises:
- tetracosactide acetate 0.25% (w/v),
- chitosan glutamate 0.5% (w/v),
- sodium chloride 0.54% (w/v),
- benzalkonium chloride 0.015% (w/v),
- acetic acid 0.51% (w/v), and
- sodium acetate trihydrate 0.21% (w/v);
- iii) repeating step i);
- iv) comparing the concentration of cortisone in the saliva sample of step (i) with the cortisol or cortisone concentration of step (iii);
- and
- (v) identifying adrenal insufficiency in the neonate or infant subject.
Dependencies are inferred from the claim text.