NCT00574223已完成2 期
Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
研究概览
简要总结
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens
排除标准
- •Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
- •Use of any concomitant medication that could affect the patient's study treatment response or assessment results
研究组 & 干预措施
Arm 1
Experimental
干预措施: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) (Drug)
Arm 2
Placebo Comparator
干预措施: House dust mite allergen extract in combination with CYT003-QbG10-placebo (Drug)
结局指标
主要结局
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
时间窗: about 1.5 hours on 4 occasions over 1 year
次要结局
- Safety and tolerability of the study treatment by collection of adverse events(about 30 min. at each visit)
研究者
研究点 (1)
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