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临床试验/EUCTR2013-003270-28-ES
EUCTR2013-003270-28-ES进行中(未招募)不适用

Biological standardization of allergenic extracts of Dermatophagoides farinae and Lolium perenne. Open label. Single Center. Phase II Study. - Biological standardization of Dermatophagoides farinae and Lolium perenne.

Instituto de Inmunología y Alergia INMUNAL S.A..U.0 个研究点开始时间: 2013年10月22日最近更新:

试验速览

阶段
不适用
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

  • - Informed consent signed and dated by the patient/witness.
  • - Patients living in an area where the allergen is considered as a relevant
  • health problem.
  • - Medical history supporting the allergy to the allergen.
  • - Positive diagnosis to the allergen
  • - Specific IgE positive for any of the allergens
  • - Age range between 18 and 64 years old for both genders
  • -Negative pregnancy test for fertile women
  • Are the trial subjects under 18? no
  • 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 50
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Patients who had received previous immunotherapy within the previous
  • - Patients who had received within the previous 15 day sany intake of
  • drugs able to interfere in the Skin Prick test (e.g. anti histaminic, topic
  • corticoids, ? blockers or tryciclic antidepresives).
  • - Pregnant women or breast feeding
  • - Patients who has received systemic corticoids (dose greater than 30 mg
  • prednisone/day) for longer than a week.
  • - Patients with cutaneous reactions which can modify the response (e.g.
  • Dermographism, dermatitis, severe asthma, hipersensibility to phenol or
  • any of the components of the prick test)

研究者

发起方
Instituto de Inmunología y Alergia INMUNAL S.A..U.

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