Respiratory allergopathy MedDRA version: 14.1 Level: PT Classification code 10054928 Term: Allergy to plants System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: PT Classification code 10001742 Term: Allergy to animal System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Allergenic extract of Dermatophagoides
Product Code: NA
Pharmaceutical Form: Solution for skin-prick test
Other descriptive name: Allergenic extracts of Dermatophagoides, Betulaceae and
Sponsors
LOFARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. subjects of both sexes, of any ethnicity, aged between 18 and 50 years (median between 20 and 30 years) with a documented history of at least two years of related allergopatia respiratory exposure to at least one of the allergens tested (Dermatophagoides, Betulaceae and Graminaceae) and who lives in areas where the presence of such allergens represents a significant problem, which is presented in a row; 2. prick-test positive with average diameter (half-sum of the larger diameter and diameter perpendicular to it) of the wheal procured from an extract already standardized, and available commercially, the allergen to be tested = 3 mm, average diameter of the wheal procured by histamine dihydrochloride 1 mg / ml (H1)> 4 mm and a mean diameter of the wheal procured from the negative control (N) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. simultaneous participation in other clinical trials or studies completed less than one month prior to enrollment; 2. previous immunotherapy in the last 5 years with a preparation of allergen known to interfere with the allergens to be tested; 3. immunotherapy in progress; 4. individuals with any relationship or dependence by the sponsor and / or investigator; 5. no pregnant or breast feeding patients; 6. immunodeficiency (eg induced by immunosuppressive drugs); 7. atopic dermatitis; 8. dermographism, 9. hives; 10. neurological and infectious diseases that can produce cutaneous anergy; 11. Abuse of alcohol or drugs; 12. taking medications that may interfere with skin reactivity; 13. treatment with tricyclic antidepressants or tetracyclic, phenothiazines, ß-blockers, dopamine, clonidine, corticosteroids (> 10 mg / day of prednisone); 14. should be suspended any oral antihistamines and topical corticosteroids for at least 7 days; 15. exposure of the execution venues to test UV rays, artificial or natural, for therapeutic or aesthetic within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The avarage diameter in mm of local skin reaction during the immediate phase of the reaction, ie 15 minutes from the execution of the test.;Main Objective: Determination of the biological activity of allergenic extracts of Dermatophagoides, Betulaceae and Graminaceae in HEP units (histamine equivalent prick) in order to define an in-house reference preparation (IHRP).;Secondary Objective: NA;Primary end point(s): Calculate the concentration of allergen can cause a response of an average diameter equal to that of the reaction caused by histamine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactServizio medico
LOFARMA
Outcome results
None listed