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

Last updated: August 4, 2010
Sponsor: Laboratorios Leti, S.L.
Overall Status: Completed

Phase

2

Condition

Common Cold

Eye Disorders/infections

Allergy

Treatment

N/A

Clinical Study ID

NCT00718744
2005-001194-96
  • Ages 18-50
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntarily signed informed consent form by the patient

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

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

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

  • A positive prick test (mean wheal diameter > 3 mm) when tested with a standardizedextract prepared from the allergen source in question and/or a positive test forspecific 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

Exclusion Criteria:

  • Immunotherapy in the past 2 years with an allergen preparation known to interfere withthe 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

Total Participants: 30
Study Start date:
June 01, 2008
Estimated Completion Date:
November 30, 2008

Study 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".

Connect with a study center

  • Hospital "Xeral de Calde"

    Calde, Lugo 27004
    Spain

    Site Not Available

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