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临床试验/EUCTR2010-020079-22-FR
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:
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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

发起方
STALLERGENES S.A.

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