Allergy to grass pollen Allergy to birch pollen Allergy to ragweed pollen Allergy to mites MedDRA version: 12.1 Level: LLT Classification code 10039085 Term: Rhinitis allergic
Conditions
Interventions
Trade Name: Alyostal prick®
Pharmaceutical Form: Cutaneous solution
Other descriptive name: Freeze dried 5 grasses pollen allergen extract
Concentration type: equal
Concentration number: 100 IR/ml-
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Sponsors
STALLERGENES S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the study. 2. Male or female subjects aged 5-60 years inclusive. 3. Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test. 4. Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass, birch or ragweed pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years). 5. Subjects affiliated to a social security system. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Dermographism. 3. Absence of cutaneous reactivity 4. Presence of cutaneous lesions on the forearms either preventing the performance of the test or which may interfere with the interpretation of the test. 5. Subjects presenting unstable asthma or poor general health condition. 6. Subjects with past or current specific immunotherapy treatment for any of the 5 tested allergens (Grass, Birch, Ragweed pollens, D. pteronyssinus and D. farinae mites) in the previous 5 years. 7. Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine. 8. Subjects on anti-IgE treatment. 9. Subjects treated with ß-blockers and/or anti-depressives. 10. Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial. 11. Investigators, co-investigators, as well as their children or spouses and all the study collaborators. 12. Subjects under protection of the courts, legal guardianship or legal trusteeship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine the sensitivity and specificity of five solutions of different allergen extracts for diagnosis by skin prick test: - 5 Grasses pollen - Birch pollen - Ragweed pollen - Dermatophagoides pteronyssinus mite - Dermatophagoides farinae mite ;Secondary Objective: Not applicable;Primary end point(s): Pharmacodynamic analysis Primary analysis: Analysis of sensitivity and specificity will be conducted on the Per Protocol Set (PPS). For each allergen, the number of "true positive" (TP) and "true negative" (TN) subjects will be assessed as the number of subjects with positive specific IgE and clinical history associated with a positive skin prick-test , and the number of subjects with negative specific IgE without clinical history associated with a negative skin prick-test, respectively. The diagnosis of the allergic disease will be established by a surrogate standard of truth defined as the concomitant presence or absence of the 2 following items: - Specific IgE dosage in blood (ImmunoCAP system) to the specified allergen, - Clinical history evocating a respiratory allergy to the specified allergen. The presence of both items will provide evidence of the true disease state. The absence of both items will exclude the diagnosis of the allergic disease. In case of discrepancy between both items, subjects will not be eligible for analysis. Data will be summarized in a diagnostic decision matrix. For each allergen, the sensitivity (Se) and the specificity (Sp) will be calculated according to: Se= TP/ (TP+FN) = TP/ N Allergic Sp=TN/ (FP+TN)= TN/ N Non allergic FP: false positive, TP: true positive FN: false negative, TN: true negative Test validation: A skin prick test reaction is positive when the mean wheal diameter is > 3 mm. A skin prick test reaction = 3 mm is negative. True disease state is defined for the two groups as follows: Disease present: clinical history of allergic respiratory disease to the consid | — |
Countries
France
Outcome results
None listed