NCT01012882Unknown3 期
A Multicenter Randomized DBPC Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy (SLIT) With Allergen Extracts From Pollen in Patients With Seasonal Allergic Rhinitis
Roxall Medizin1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年11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
- 120
- 试验地点
- 1
- 主要终点
- Symptom and medication score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .
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 allergen specific seasonal 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 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
- Clinical global improvement(1 year)
- Safety of the treatment(1 year)
- Documentation of adverse events(1 year)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(1 year)
研究者
研究点 (1)
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