NCT00857779已完成2 期
A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 473
- 试验地点
- 1
- 主要终点
- IgE-blocking factor
研究概览
简要总结
The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ
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
- None
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
- •A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- •Lack of adequate relief with symptomatic medication during the previous grass pollen season
- •Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening
排除标准
- •FEV1 < 70% of predicted value at screening
- •Bronchial asthma corresponding to GINA step 3 or more, even if controlled
- •History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
- •Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
- •Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ
研究组 & 干预措施
subcutaneous immunotherapy
Active Comparator
subcutaneous immunotherapy using a slow updosing schedule
干预措施: subcutaneous immunotherapy (Biological)
subcutaneous injections
Active Comparator
subcutaneous immunotherapy using a fast updosing schedule
干预措施: subcutaneous immunotherapy (Biological)
结局指标
主要结局
IgE-blocking factor
时间窗: start of treatment and 1 week after end of treatment
次要结局
- Tolerability of two different updosing schedules(throughout treatment)
研究者
研究点 (1)
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