EUCTR2016-000154-34-DE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
适应症
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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