Allergy to mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae MedDRA version: 18.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: Dermatophagoides pteronyssinus 300 mcg/ml allergen extract
Product Code: M601
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Dermatophagoides pteronyssinus 300mcg/ml allerg
Sponsors
Inmunotek, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae. -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 area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2. -Age: over 18 years of age. -Both sexes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Subjects outside of the age range. -Individuals 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 extract mixture of Dermatophagoides pteronyssinus or farinae. -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 in treatment 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 or women at risk of pregnancy and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The evaluation of the primary end point will be once the data base has been closed.;Main Objective: The main objective is to assess the concentration of extract allergen of Dermatophagoides pteronyssinus and Dermatophagoides farinae causing a papula of a size equivalent to that produced by a solution of dihidroclorhidrato of histamine to 10 mgml.;Secondary Objective: N/A;Primary end point(s): The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas; Medical Director
Inmunotek, S.L.
Outcome results
None listed