EUCTR2016-000155-28-GB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 in Subjects With Moderate to Very Severe COPD - SOPHOS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,860
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
- •Inclusion Criteria:
- •1. Give their signed written informed consent to participate
- •2. At least 40 years of age and no older than 80 years of age
- •3. Moderate to Very Severe COPD patients who are symptomatic
- •4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
- •5. Must have a documented history of COPD exacerbations
- •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 1023
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 837
排除标准
- •Exclusion Criteria:
- •1.Current diagnosis of asthma
- •2.COPD due to a1-Antitrypsin Deficiency
- •3. Known active tuberculosis, lung cancer, cystic fibrosis, and 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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