EUCTR2010-020079-22-FR
Active, not recruiting
Phase 1
Determination of sensitivity and specificity of five solutions of allergen extract (5 grasses, birch, ragweed pollens and Dermatophagoides pteronyssinus and Dermatophagoides farinae mites) for diagnosis by skin prick testing. - Sensitivity and specificity of solutions for diagnosis by skin prick-test
STALLERGENES S.A.0 sitesMay 11, 2010
DrugsAlyostal prick®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- STALLERGENES S.A.
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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