NCT00206167已完成3 期
A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
适应症
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
- 1,600
- 试验地点
- 217
- 主要终点
- Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
研究概览
简要总结
The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with 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
- Double
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 clinical diagnosis of COPD with symptoms for more than 2 years.
- •Smoking history of 10 or more pack years
- •A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.
排除标准
- •A history of asthma
- •Patients taking oral steroids
- •Any significant disease or disorder that may jeopardize the safety of the patient
结局指标
主要结局
Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
次要结局
- Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
- Health care utilization
- Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
- all variables assessed over the 12 months treatment period
研究者
研究点 (217)
Loading locations...
相似试验
已完成
3 期
New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a DayAsthmaNCT01360021AstraZeneca214
已完成
3 期
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPDChronic Obstructive Pulmonary DiseaseNCT00419744AstraZeneca1,200
已完成
3 期
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and AdolescentsAsthmaNCT01444430AstraZeneca12,460
已完成
3 期
DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in AdultsAsthmaNCT00252863AstraZeneca1,600
已完成
3 期
SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and AdultsAsthmaNCT00259792AstraZeneca1,000