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临床试验/EUCTR2016-000154-34-PL
EUCTR2016-000154-34-PL进行中(未招募)1 期

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®,as an Active Control, on Lung Function over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD - TELOS

Pearl Therapeutics, Inc.0 个研究点目标入组 2,420 人开始时间: 2016年11月10日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
2,420

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

  • 1. Give their signed written informed consent to participate
  • 2. Are at least 40 years of age and no older than 80 years
  • 3. Moderate to very severe COPD patients who are symptomatic
  • 4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
  • 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 1310
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1110

排除标准

  • 1. Current diagnosis of asthma,
  • 2. COPD due to a1-Antitrypsin Deficiency
  • 3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
  • 4. Long-term-oxygen therapy (= 15 hours a day).

研究者

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