Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units
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 |
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
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. |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Spain | Hospital "Xeral de Calde" | Calde | Lugo |
Lead Sponsor | Collaborator |
---|---|
Laboratorios Leti, S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wheal size area (mm2) of the immediate phase reaction. | 30 minutes per subject | No |
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