Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Leti Pharma

Status and phase

Completed

Phase 2

Conditions

Allergy to Tree Pollen

Treatments

Biological: Cupressus arizonica

Study type

Interventional

Funder types

Industry

Identifiers

NCT02512653

608-PR-PRI-199

Details and patient eligibility

About

Biological Standardization of Cupressus arizonica Allergen Extract.

Full description

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Enrollment

33 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has provided written informed consent, appropriately signed and dated by subject.
Subject can be male or female of any race and ethinic group.
Age 18 years and 60 years ata the study inclusión day.
Positive clinical history of inhalatory allergy to Cupressus arizonica.
A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
A positive prick test with positive control of histamine 10 mg/ml.
A positive test for specific IgE to Cupressus arizonica.

Exclusion criteria

Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
Use of drugs that may interfere before and after with the skin reactions.
Treatment with certain drugs.