EUCTR2008-003879-49-GB
进行中（未招募）
不适用
A double-blind, randomised, placebo controlled, phase I/IIa dose escalation study to investigate the safety and the effect of different doses of Oralgen House Dust Mite in patients with house dust mite induced allergic rhinoconjunctivitis
Artu Biologicals Europe B.V.0 个研究点2008年6月27日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Artu Biologicals Europe B.V.
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female between 18 and 60 years of age (inclusive).
- •2\. House\-dust mite induced allergy with moderate to severe rhinitis symptoms
- •for at least one year.
- •3\. RRTSS score of greater than or equal to 10 out of a maximal score of 18\.
- •4\. Sensitized to D pter and D far as indicated by a specific RAST of at least
- •class 2 and a positive skin prick test (i.e. wheal diameter equal to or more
- •than 3 mm larger than the negative diluent control).
- •5\. Positive D pter nasal provocation test at screening.
- •6\. Patients who have been informed of the nature and aims of the study and
- •have given their written consent to participate in this study.
排除标准
- •1\. Other clinically relevant allergies (perennial or seasonal) that could potentially
- •interfere with the patient's study treatment schedule or assessments. Patients
- •with allergic rhinoconjunctivitis due to allergens to which the patient is not
- •exposed to during the study are allowed into the study.
- •2\. Patients who lack general good health as determined by past medical history,
- •physical examination, 12\-lead ECG and safety laboratory tests.
- •3\. Patients with a past or current disease, which as judged by the investigator,
- •may affect the patient’s participation in or the outcome of this study.
- •4\. Abnormal spirometry: Forced Expiratory Volume in 1 second (FEV1\) at least
- •80% of the predicted value at screening.
结局指标
主要结局
未指定
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