JPRN-UMIN000020020已完成未知
Clinical benefits of twice daily medication of Aclidinium Bromide Compared with once daily medication of Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - Command Study Clinical benefits of Aclidinium Bromide Compared with Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)
Kamei Internal Medicine and Respiratory Clinic0 个研究点目标入组 60 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients who meet any of the conditions below at Visit 1 will not be eligible as subjects. (1)History and concurrent medical conditions -Having bronchial asthma -Having pulmonary fibrosis definitely diagnosed by CT or HRCT (high-resolution CT) -Having respiratory tract infection (including upper-airway inflammation) within the past 4 weeks -Having hospitalization due to acute exacerbation of COPD within the past 3 months -Having serious complications such as respiratory, cardiac, hepatic, renal, pulmonary, or hematologic disease or others that would interfere with participation in the study -Having malignant tumor or a history of malignant tumor within the past 5 years -Having contraindication of anticholinergic agents (2)Medications and therapies -Either or both of ICS and ICS/LABA agents has been switched or planned to be switched within the 4 weeks prior to patient enrollment during the run-in/treatment periods or planned to be switched Use of anticholinergic agents (inhaled, oral, etc.) -LABA has been switched or planned to be switched during the run-in period -Use of cholinesterase inhibitors -Use of systemic steroids* -Use of theophylline products* except for sustained-release oral theophylline products *Except for the treatment of COPD exacerbation -Patients under oxygen therapy for more than 15 hours a day -Patients whoes pulmonary rehabilitation program has been changed within the past 6 weeks -Patients under acute-phase pulmonary rehabilitation program -Patients under non-invasive ventilation -Patients having a history of side effects anticholinergic agents (3)Others -Patients who cannot use inhaler correctly -Patients who cannot perform a respiratory function test properly -Patients who hope to change their smoking habit -Women who are pregnant, lactating, or hoping to become pregnant during the study period -Patients who have been judged ineligible for the study by the investigator or sub-investigator
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