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临床试验/EUCTR2010-020141-26-DE
EUCTR2010-020141-26-DE进行中(未招募)不适用

A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an oral tablet in Subjects with Mild COPD Following Segmental Endobronchial LPS Instillation. - Investigation of the effect of oral treatment with 100mg AZD2423 in subjects with mild COPD.

AstraZeneca AB0 个研究点开始时间: 2010年7月8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

  • For inclusion in the study subjects should fulfil the following criteria:
  • 1- Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
  • 2- = 40 years of age at Visit 1
  • 3- Clinical diagnosis of COPD (GOLD stage 1)
  • 4- FEV1 = 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
  • 5- FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 4

排除标准

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • 1- Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
  • 2- Any clinically relevant abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability or take part or influence the results of the study
  • 3- A past history or current indication of renal (kidney) failure
  • 4- Subjects at risk of active tuberculosis or of disease reactivation
  • 5- Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)

研究者

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