NCT01397890已完成4 期
A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort® Turbuhaler® 160/4.5μg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 μg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 μg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 793
- 试验地点
- 1
- 主要终点
- Pre-dose FEV1
研究概览
简要总结
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (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
- •Signed and dated informed consent
- •Men or women patients ≥40 years of age
- •Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
- •Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 70%, pre-bronchodilator
- •Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
排除标准
- •A history of asthma and seasonal allergic rhinitis before 40 years of age
- •Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
- •Patients with relevant cardiovascular disorder judged by the investigator
- •Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
- •Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
研究组 & 干预措施
1
Other
Add-on treatment
干预措施: Budesonide/formoterol (Symbicort® Turbuhaler®) (Drug)
1
Other
Add-on treatment
干预措施: Tiotropium (SpirivaTM) (Drug)
2
Other
Add-on treatment
干预措施: Tiotropium (SpirivaTM) (Drug)
结局指标
主要结局
Pre-dose FEV1
时间窗: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value
次要结局
- Post-dose FEV1 at 5 Minutes(Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug)
- Post-dose FEV1 at 60 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
- Pre-dose IC(Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug)
- Pre-dose PEF in Last Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks)
- Post-dose PEF in Last Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks)
- Pre-dose FVC(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
- Pre-dose PEF in First Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment)
- Post-dose PEF in First Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment)
- Post-dose PEF in Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks)
- Use of Reliever Medication During Night in the Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks)
- Change in COPD Symptoms - Cough(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks)
- Change in COPD Symptoms - Sputum(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks)
- Post-dose FVC at 5 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12))
- Post-dose IC at 60 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
- Use of Reliever Medication During Day in the First Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment)
- Post-dose FVC at 60 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
- Change in COPD Symptoms - Breathing(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks)
- Use of Reliever Medication During Night in the Last Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks)
- Pre-dose PEF in Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks)
- Use of Reliever Medication During Day in the Last Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks)
- Use of Reliever Medication During Day in the Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks)
- Use of Reliever Medication During Night in the First Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment)
- COPD Exacerbations(Whole treatment period of 12 weeks)
研究者
研究点 (1)
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