A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Standardized Dyspnea Score at Isotime During Exercise
研究概览
简要总结
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising 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
- Crossover
- 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
- •40 years and older
- •Clinical diagnosis of COPD for greater than one year
- •History of cigarette smoking
排除标准
- •Other lung diseases (not including COPD), such as asthma
- •A condition that could interfere with your ability to perform exercise tests
研究组 & 干预措施
2
Arm 2: Pbo comparator, crossing over to drug
干预措施: Fluticasone (Drug)
1
Arm 1: drug, crossing over to Pbo comparator
干预措施: Fluticasone (Drug)
结局指标
主要结局
Standardized Dyspnea Score at Isotime During Exercise
时间窗: 2 Weeks
Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 \[Best\] - 10 \[Worst\] ).
次要结局
- Exercise Endurance Time(2 Weeks)