NCT00421122已完成3 期
A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Post-study medication FEV1
研究概览
简要总结
This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated inform consent
- •Out-patient, clinical diagnosis of COPD
- •Men or women at the age of 40 or over
排除标准
- •A history of asthma
- •Seasonal allergic rhinitis before 40 years of age
- •Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder
研究组 & 干预措施
1
Active Comparator
Bricasol®
干预措施: terbutaline sulfate (Bricasol) (Drug)
2
Experimental
Bricasol® + Pulmicort®
干预措施: budesonide (Pulmicort) (Drug)
2
Experimental
Bricasol® + Pulmicort®
干预措施: terbutaline sulfate (Bricasol) (Drug)
3
Experimental
Bricasol® + Symbicort®
干预措施: budesonide/formoterol (Symbicort) (Drug)
3
Experimental
Bricasol® + Symbicort®
干预措施: terbutaline sulfate (Bricasol) (Drug)
结局指标
主要结局
Post-study medication FEV1
时间窗: 1 hour after medication
次要结局
- vital signs
- lab measures
- ECG
- physician examination
- AE
- FVC(Pre dose and 1 hour post dose)
- reliever medication use
- FEV1(Pre-dose and 15 minutes post dose)
- SGRQ symptom scores
- morning and evening PEF(Assessed daily)
- COPD symptom scores
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease (COPD)NCT01415518AstraZeneca581
已完成
3 期
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in JapanChronic Obstructive Pulmonary DiseaseNCT01070784AstraZeneca328
已完成
3 期
Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With AsthmaAsthmaNCT00255255AstraZeneca120
已完成
3 期
Long-Term Safety of Symbicort in Asthmatic Children - SAPLINGAsthmaNCT00646529AstraZeneca175
已完成
不适用
Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever TherapyBronchial AsthmaNCT01711840AstraZeneca2,409