Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo
研究概览
详细说明
Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.
Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.
In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Berlin、德国、13353
- Klinik für Paediatrie Universitätsmedizin Berlin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 4 - <12 years (at the time of inclusion)
- Positive SPT
- Positive EAST
- Positive CPT
Exclusion Criteria:
- Serious chronic diseases
- Other perennial allergies
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Immunotherapy
Grass pollen allergens in a water/glycerol solution
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In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
其他名称:
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安慰剂比较:Placebo
Water/glycerol solution with phosphate buffered saline
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Placebo was given in the same way as the sublingual active treatment.
Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Changes of Symptom-Medication-Score
大体时间:After 1 year of treatment
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The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.
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After 1 year of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Evaluation of the documentation of adverse events (AEs)
大体时间:Entire treatment period
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Safety of treatments during the entire treatment period.
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Entire treatment period
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合作者和调查者
调查人员
- 首席研究员:Ulrich Wahn, MD、Charite University, Berlin, Germany
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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