EUCTR2019-002644-24-ES进行中（未招募）1 期
Biological standarization of allergic extracts of will grasses: Phleum pratense, Lolium perenne, Poa pratensis y Dactylis glomerata and its mixture to determinate their biological activity, the In House Reference Preparation, measures in histamine unit equivalents (HEP) in sensitized patients
Diater, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas S.A.0 个研究点目标入组 120 人开始时间: 2019年12月2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
- 120
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 patients/witness.
- •Age range between 18 and 65 years old for both sexs.
- •Positive case history with inhalant allergy to exposure to the allergen.
- •Positive diagnosis to the allergens by SPT
- •Specific IgE positive for any of the allergens
- •Negative pregnancy in urine 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 120
- •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 Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergens to be tested.
- •Use of drugs which may interfere with the skin reaction (antihistaminic drugs received in the previous 7 days, oral corticoids, tricyclic antidepressants, MAOI, beta blockers).
- •Pregnant women or breast feeding.
- •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, urticaria).
- •Patients treated with pimecrolimus and/or topic corticoids within the previous 21 days.
- •Immune system diseases clinically relevant.
- •Uncontrolled diseases severe that may increase the risk to the safety of patients participating in this study.
- •Patients with diseases or disorders that limit the use of adrenaline.
- •Patients with a history of serious reactions during the course of previous skin tests.
- •Patients who have received anti-IgE treatment (Omalizumab).
- •Patients participating in another clinical trial
研究者
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