NCT00496470已完成4 期
A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
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
- 660
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
研究概览
简要总结
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN
排除标准
- •Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
研究组 & 干预措施
Symbicort+TIO
Active Comparator
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
干预措施: Symbicort (budesonide/formoterol turbuhaler 320/9ug) (Drug)
Spiriva® + Placebo Turbuhaler
Active Comparator
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
干预措施: Spiriva (tiotropium bromide 18ug) (Drug)
结局指标
主要结局
Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
时间窗: Baseline to 12 weeks
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
次要结局
- Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose(Baseline to 12 weeks)
- Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose(Baseline to 12 weeks)
- Forced Vital Capacity (FVC) Pre-dose(Baseline to 12 weeks)
- Morning Peak Expiratory Flow (PEF) 5 Min Post-dose(Baseline to 12 weeks)
- Forced Vital Capacity (FVC) 5 Minutes Post-dose(Baseline to 12 weeks)
- Forced Vital Capacity (FVC) 60 Minutes Post-dose(Baseline to 12 weeks)
- Inspiratory Capacity (IC) Pre-dose(Baseline to 12 weeks)
- Inspiratory Capacity (IC) 60 Minutes Post-dose(Baseline to 12 weeks)
- St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score(Baseline and 12 weeks)
- Morning Peak Expiratory Flow (PEF) Pre-dose(Baseline to 12 weeks)
- Evening Peak Expiratory Flow (PEF) Pre-dose(Baseline to 12 weeks)
- Morning Peak Expiratory Flow (PEF) 15 Min Post-dose(Baseline to 12 weeks)
- Morning Diary FEV1 Pre-dose(Baseline to 12 weeks)
- Evening Diary FEV1, Pre-dose(Baseline to 12 weeks)
- Morning Diary FEV1, 5 Minutes Post-dose(Baseline to 12 weeks)
- Morning Diary FEV1, 15 Minutes Post-dose(Baseline to 12 weeks)
- Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose(Baseline to 12 weeks)
- GCSQ Score, 5 Minutes Post-dose(Baseline to 12 weeks)
- GCSQ Score, 15 Minutes Post-dose(Baseline to 12 weeks)
- Capacity of Day Living in the Morning (CDLM) Score(Baseline to 12 weeks)
- Use of Rescue Medication, Night(Baseline to 12 weeks)
- Use of Rescue Medication, Morning(Baseline to 12 weeks)
- Use of Rescue Medication, Day(Baseline to 12 weeks)
- Use of Rescue Medication, Total(Baseline to 12 weeks)
- COPD Symptoms, Breathing Score(Baseline to 12 weeks)
- COPD Symptoms, Sleeping Score(Baseline to 12 weeks)
- COPD Symptoms, Chest Score(Baseline to 12 weeks)
- COPD Symptoms, Cough Score(Baseline to 12 weeks)
- Severe COPD Exacerbations(12 weeks)
- Serum High-sensitivity C-reactive Protein (hsCRP)(Baseline to 12 weeks)
- Serum Interleukin 6 (IL-6)(Baseline to 12 weeks)
- Serum Interleukin 8 (IL-8)(Baseline to 12 weeks)
- Serum Monocyte Chemoattractant Protein-1 (MCP-1)(Baseline to 12 weeks)
- Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)(Baseline to 12 weeks)
- Serum Tumor Necrosis Factor-alpha (TNF-alpha)(Baseline to 12 weeks)
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)(Baseline to 12 weeks)
研究者
研究点 (1)
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