Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended
The objective of this study is to determine the biologic activity of a Glycyphagus
domesticus allergen extract in histamine equivalent prick (HEP) units, in order to be used
as in-house reference preparation (IHRP).
The skin testing procedure, based on the Nordic Guidelines is the reference method for the
biological calibration of in-House Reference Preparations (IHRP). The method is not intended
for routine testing of allergen extracts. The use of this procedure is the basis for the
definition of biological activity units: "the activity of an allergen extract is 10,000
Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin
reaction in the median sensitive patient with a wheal of the same size as a wheal provoked
by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine
dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique
(prick testing) on at least 20 individuals who are clinically allergic and cutaneously
reactive to the allergen concerned".
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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