NCT01012752Unknown3 期
A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis
Roxall Medizin1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年10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
- 150
- 试验地点
- 1
- 主要终点
- Symptom and medication score
研究概览
简要总结
This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
- •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 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 the treatment(1 year)
- Documentation of adverse events(1 year)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(1 year)
- Clinical global improvement(1 year)
研究者
研究点 (1)
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