Symbicort in Chronic Obstruktive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 18,014
- 主要终点
- efficacy and tolerability of budesonide /formoterole in subjects with COPD who are treated by general practitioners and internists.
研究概览
简要总结
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e.general practitioners and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD treated with budesonide/formoterol
排除标准
- •limitiations; possible risks; warnings; contraindications mentioned in the SPC.
结局指标
主要结局
efficacy and tolerability of budesonide /formoterole in subjects with COPD who are treated by general practitioners and internists.
时间窗: change of a quality of life score compared to baseline by using CRQ, stratified by present therapy and severity of COPD; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE under outpatient medical care conditions
次要结局
- to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population