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临床试验/EUCTR2009-014580-39-DE
EUCTR2009-014580-39-DE进行中(未招募)不适用

A multicentre randomised Phase II clinical pilot study to compare the pharmacodynamic efficacy and tolerability of the sublingual and the vestibular administration route for SLITonePLUS® Birch

ALK-Abelló Arzneimittel GmbH0 个研究点开始时间: 2009年10月12日最近更新:

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

  • Male and female patients 18-65 years who have given written informed consent, with the following main inclusion criteria:
  • A clinical history of birch pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the birch pollen season
  • Lack of adequate relief with symptomatic medication during the previous pollen season
  • Positive Skin Prick Test (SPT) response to Betula verrucosa (wheal diameter = 3 mm) currently performed or not older than 60 days before screening
  • Positive specific IgE against Betula verrucosa (IgE Class = 2).
  • 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)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Uncontrolled or severe asthma (FEV1 < 70% of predicted value in spite of adequate pharmacologic treatment)
  • History of emergency visit or admission for asthma in the previous12 months
  • Previous treatment by immunotherapy with birch or tree pollen allergen within the previous 5 years
  • Exclusion criteria in accordance with contraindications in the SmPC of SLITonePLUS.

研究者

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