Determination of the sensitivity and specificity of prick test Betula verrucosa

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 198

Inclusion Criteria

- Positive clinical history or not of inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) from Betula verrucosa
-Allergic subjects, must submit a prick-test positive (average of the papule > 3 mm diameter) with a summary of the same allergen I presence against the allergen specific IGE.
-The average diameter of the papule obtained by histamine dihydrochloride to 10 mgml must be >3mm
- Age: from 5 to 70 years.
- They must be capable of giving informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

- Subjects outside of the age range.
- Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the allergen from Betula extract verrucosa
- Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated.
- Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests.
- Subjects treated with ss-blockers.
- Unstable subjects of clinical point of view (asthma acute, febrile, etc).
- Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives).
-Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test.
- Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
- States of the subject that can not offer cooperation and severe psychiatric disorders.
- Pregnant women at risk of pregnancy and breastfeeding women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.;Secondary Objective: N/A;Primary end point(s): The main objective is to assess the concentration of Betula verrucosa allergen extract that elicit a papula of a equivalent size to that produced by a solution of histamine dihidroclorhidrato 10 mgml.;Timepoint(s) of evaluation of this end point: The evaluation of the primary end point will be once the data base has been closed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: N/A

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