NCT00206154已完成3 期
A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
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
- 1,500
- 试验地点
- 210
- 主要终点
- Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
研究概览
简要总结
The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with 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 6 months treatment period
次要结局
- Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
- Health care utilization
- Pharmacokinetics (subgroup)
- Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
- - all variables assessed over the 6 months treatment period
研究者
研究点 (210)
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