NCT00419744已完成3 期
A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
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
- 1,200
- 试验地点
- 140
- 主要终点
- Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
研究概览
简要总结
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
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 current clinical diagnosis of COPD with COPD symptoms for more than 2 years
- •Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
- •A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit
排除标准
- •A history of asthma at or after 18 years of age
- •A history of allergic rhinitis at or after 18 years of age
- •Subjects taking oral steroids
- •Any significant disease or disorder that may jeopardize a subject's safety
结局指标
主要结局
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
时间窗: 12 months
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of Exacerbations Per Subject-year
时间窗: 12 months
Rate of exacerbations per subject-year
次要结局
- Pre-dose Forced Expiratory Volume in 1 Second (FEV1)(12 months)
- Morning Peak Expiratory Flow (PEF)(12 months)
- Evening PEF(12 months)
- Dyspnea Symptom Scores(12 months)
- Use of Rescue Medication(12 months)
- St. George's Respiratory Questionnaire (SGRQ) Score(12 months)
研究者
研究点 (140)
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