NCT02850978已完成不适用
Post-marketing Surveillance (PMS) on Long-term Use of Tiotropium+Olodaterol Fixed Dose Combination (Tio+Olo FDC) 5µg/5µg in Patients With Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,335
- 主要终点
- Percentage of Participants With Adverse Drug Reactions
研究概览
简要总结
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Spiolto
Patient with COPD to received Spiolto
干预措施: Spiolto (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions
时间窗: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".
次要结局
- Change of COPD Assessment Test (CAT) Score From Baseline to Week 12(Baseline and Week 12)
研究者
相似试验
已完成
不适用
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid ArthritisRheumatoid Arthritis (RA)NCT03971253Astellas Pharma Inc3,000
已完成
不适用
A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)CancerChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Leukemia (SLL)NCT04198415AbbVie4
已完成
不适用
Efficacy and Safety of Cilostazol for the Indication of CSPSCerebral InfarctionNCT00216749Korea Otsuka Pharmaceutical Co., Ltd.650
已完成
不适用
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseParkinson DiseaseNCT01525641Boehringer Ingelheim615
已完成
不适用
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without DilutionInfectionNCT01690559Bayer704