EUCTR2008-006921-14-DE进行中（未招募）不适用
A multicentre randomised Phase II clinical trial to demonstrate equivalent pharmacodynamic efficacy and tolerability of two updosing schedules for ALK-Flex SQ
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 pollen season
- •Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter = 3 mm) currently performed or not older than 60 days before screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 4 grass mix + rye.
研究者
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