Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718744
• Other study ID #: 2005-001194-96
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2008
• Last updated: August 4, 2010
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2010
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Voluntarily signed informed consent form by the patient

• Patients should live in a geographic zone where allergy caused by Chortoglyphus arcuatus is a relevant problem.

• Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfil the inclusion criteria.

• A positive case history with inhalant allergy related to exposure to the allergen to be tested.

• A positive prick test (mean wheal diameter > 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE.

• A mean wheal diameter > 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.

• Age: 18-50 years.

• Both genders

Exclusion Criteria:

• Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.

• Use of drugs that may interfere with the skin reactions.

• Pregnancy

• Dermographism

• Atopic dermatitis (locally at the test site)

• Urticaria.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Other:
• Standardization of allergenic extract (Ch. arcuatus)
Allergenic extract for cutaneous prick-test

Locations

Country	Name	City	State
Spain	Hospital "Xeral de Calde"	Calde	Lugo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheal size area (mm2) of the immediate phase reaction.		30 minutes per subject	No