EUCTR2006-004610-41-DE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva (R) HandiHaler (R)) 18 µg once daily (EXACTT trial) - EXACTT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 460
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
- •- Male or female
- •-40 years old or more
- •-with a diagnosis of COPD (pre-bronchodilator FEV1 60% or less than predicted, post bronchodilator FEV1 65% or less than predicted, FEV1/FVC less than 70%)
- •-smoking history 10 or more pack-years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-history of asthma
- •-use of supplemental oxygen therapy
- •-recent history of MI
- •-history of thoracotomy with pulmonary resection
- •-chronic use of systemic corticosterids in an unstable daily dose (< 6 weeks) or a daily dose of>10 mg of prednisone or equivalent
- •-BPH or bladder neck obstruction; narrow angle glaucome; moderate to severe renal impairment; active tuberculosis
- •-BMI < 18 kg/m2 or >35 kg/m
研究者
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