A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percent of sputum neutrophils
研究概览
简要总结
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
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 (Participant, Investigator)
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
- •Diagnosis of COPD.
- •Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
- •Ex-Smokers with at least a 10 pack-year history.
排除标准
- •Current of secondary diagnosis of asthma or current diagnosis of atopy.
- •Other respiratory disorders other than COPD.
- •Other inflammatory diseases.
- •Abnormal and clinically significant chest x-ray or ECG.
- •Lung resection surgery within past 1 year.
- •History of cancer not in remission within past 2 years.
- •Serious, uncontrolled disease.
- •Pregnancy or planning to become pregnant during the study.
研究组 & 干预措施
Arm 1
干预措施: Salmeterol (Drug)
Arm 1
干预措施: Fluticasone Propionate/Salmeterol Combination Product (Drug)
结局指标
主要结局
Percent of sputum neutrophils
次要结局
- Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms