NCT01014325Unknown3 期
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
Roxall Medizin1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Symptom and medication score
研究概览
简要总结
The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive history of perennial allergic rhinitis
- •Positive screening skin prick test (wheal diameter > 3 mm)
- •Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- •Signed and dated patient´s Informed Consent,
排除标准
- •Previous immunotherapy with allergen extracts within the last 3 years,
- •Simultaneous participation in other clinical trials,
- •Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- •Auto-immune disorders,
- •Severe chronic inflammatory diseases,
- •Malignancy,
- •Alcohol abuse,
- •Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
- •Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
结局指标
主要结局
Symptom and medication score
时间窗: 1 year
次要结局
- Safety of sublingual application(1 year)
- Protocol of adverse events(1 year)
- Quality of Life Questionnaire(1 year)
- Evaluation of patients' related clinical global improvement(1 year)
研究者
研究点 (1)
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