An Open-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Clinical Laboratory Test: Haematology -Haemoglobin
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.
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
- None
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
- •A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
- •Documented COPD symptoms for more than 2 years
- •Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%
排除标准
- •History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
- •Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
- •COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.
研究组 & 干预措施
1
干预措施: Symbicort Turbuhaler (Budesonide/formoterol) (Drug)
结局指标
主要结局
Clinical Laboratory Test: Haematology -Haemoglobin
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Leucocytes
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Platelet Count
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Eosinophils
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Basophils
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Lymphocytes
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Monocytes
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Neutrophils
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Erythrocytes
时间窗: Baseline and 52 week after
Mean change from Baseline
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
时间窗: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
时间窗: Baseline and 52 week after
Change from baseline
Vital Signs- Sitting Systolic Blood Pressure(SBP)
时间窗: Baseline and 52 week after
Change from baseline
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
时间窗: Baseline and 52 week after
Change from baseline
Vital Signs- Pulse Rate
时间窗: Baseline and 52 week after
Change from baseline
ECG Variables - Heart Rate
时间窗: Baseline and 52 week after
Change from baseline
ECG Variables - QT Interval
时间窗: Baseline and 52 week after
Change from baseline
ECG Variables - QTcB Interval
时间窗: Baseline and 52 week after
Change from baseline
ECG Variables - QTcF Interval
时间窗: Baseline and 52 week after
Change from baseline
ECG Variables - RR Interval
时间窗: Baseline and 52 week after
Change from baseline
次要结局
- Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening(Daily during run-in period and daily during 52-week randomization treatment)
- Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness(Daily during run-in period and daily during 52-week randomization treatment)
- Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough(Daily during run-in period and daily during 52-week randomization treatment)
- Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic(Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization)
- Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic(Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization)
- Time to First COPD Exacerbation(Daily during 52-week randomization treatment)
- Number of COPD Exacerbations Over the Study Treatment Period(Daily during 52-week randomization treatment)
- Rescue Medication Use(Daily during 52-week randomization treatment)
- Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)(Daily during run-in period and daily 52-week randomization treatment)
- Morning Peak Expiratory Flow (PEF) Measured at Home(Daily during run-in period and daily 52-week randomization treatment)
- Evening Peak Expiratory Flow (PEF) Measured at Home(Daily during run-in period and daily 52-week randomization treatment)
- Morning FEV1 Measured by the Subjects at Home(Daily during run-in period and daily 52-week randomization treatment)
- Evening FEV1 Measured by the Subjects at Home(Daily during run-in period and daily 52-week randomization treatment)