EUCTR2010-020079-22-FR进行中(未招募)1 期
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 个研究点开始时间: 2010年5月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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