NCT01012531已完成3 期
Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization
Roxall Medizin1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 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 study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
- •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 grass and/or rye pollen 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,
- •Patients being in any relationship or dependency with the sponsor and/or investigator,
- •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
- Documentation of adverse events(1 year)
- Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season(1 year)
- Safety of the treatment during the study period(1 year)
- Global evaluation and Quality of life questionnaire(1 year)
研究者
研究点 (1)
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Efficacy and safety of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® (glutaraldehyde-polymerized allergen extract of mixtures of grass and rye allergens – Holcus lanatus, Dactylis glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca elatior, Secale cereale) in patients with allergic rhinoconjunctivitis sensitized to grass and with or without rye pollen sensitization. A prospective, double-blind, randomized, placebo-controlled, multi-centre trial. - Specific Immunotherapy with CLUSTOID®: Efficacy and safetyThis clinical trial will evaluate the benefit of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® over placebo in patients with allergic rhinoconjunctivits.EUCTR2008-000513-29-DEROXALL Medizin GmbH
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