EUCTR2012-005362-35-ES进行中（未招募）1 期
Biological standardization of pollen of Phleum pratense, Olea europaea, mite extract Dermatophagoides pteronyssinus and animal allergen Felis domesticus. Open label, single center, phase II study.
Instituto de Inmunología y Alergia INMUNAL SA0 个研究点目标入组 100 人开始时间: 2013年2月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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 inan 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 100
- •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 2 years
- •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
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