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

Phase 1

• Conditions: Allergy to grass pollenAllergy to birch pollenAllergy to ragweed pollenAllergy to mites; MedDRA version: 12.1Level: LLTClassification code 10039085Term: Rhinitis allergic

• Registration Number: EUCTR2010-020079-22-FR
• Lead Sponsor: STALLERGENES S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-11
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified