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临床试验/EUCTR2014-003155-57-DE
EUCTR2014-003155-57-DE进行中(未招募)不适用

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled study to investigate the efficacy and safety of 52 weeks treatment with QGE031 s.c. in Asthma Patients not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS

ovartis Pharma Services AG0 个研究点目标入组 440 人开始时间: 2015年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
440

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 diagnosis of allergic asthma, uncontrolled on current medication.
  • History of at least 2 asthma exacerbations during the last 1 year
  • Forced Expiratory Volume in one second (FEV1) of = 40% and = 80%
  • of the predicted normal value; reversibility following administration of
  • bronchodilator.
  • 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 293
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 147

排除标准

  • Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
  • Recent asthma attack/exacerbation or asthma worsening/ respiratory

研究者

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