Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing

Study Overview
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Brief Summary
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A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test: 5 Grasses pollen, Birch pollen, Dermatophagoides pteronyssinus mite

Official Title
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Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing

Conditions
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Allergy

Intervention / Treatment
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* Other: Skin prick-test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent to participate in the study Male or female subjects aged 5-60 years inclusive Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years) Subjects affiliated to a social security system Exclusion Criteria: Pregnant or breastfeeding women Dermographism Absence of cutaneous reactivity Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test Subjects presenting unstable asthma or poor general health condition Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine Subjects on anti-IgE treatment Subjects treated with beta-blockers and/or anti-depressives. Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial Investigators, co-investigators, as well as their children or spouses and all the study collaborators Subjects under protection of the courts, legal guardianship or legal trusteeship

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Skin prick-test|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative. |  | For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One of the secondary measurement was the wheal diameter for each allergen. |  | SPT measurements were performed after the study visit, an expected average of 1 week. |