Allergy to Betula verrucosa MedDRA version: 16.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: Betula verrucosa 100 HEP/ml allergen extract
Product Code: T502
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Betula verrucosa allergen extract 100 HEP/ml for prick test
O
Sponsors
INMUNOTEK, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas
Inmunotek, S.L.
Outcome results
None listed