NCT01344655已完成4 期
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Respiratory Impedance by Impulse oscillometry
研究概览
简要总结
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.
详细描述
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with a clinical diagnosis of COPD
- •Post bronchodilator FEV1 between 30% and 80% predicted values at screening
- •Post-bronchodilator FEV1/FVC < 0.7
排除标准
- •Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
- •History of another medical condition contraindicating participation in the study
- •Clinical evidence of heart failure
研究组 & 干预措施
Formoterol 12 μg pMDI (Atimos®)
Experimental
干预措施: Atimos® (Drug)
Salmeterol 25 µg pMDI HFA (Serevent™)
Active Comparator
干预措施: Serevent™ (Drug)
Matched Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Respiratory Impedance by Impulse oscillometry
时间窗: from 5 minutes to 8 hours post dose
次要结局
- Exhaled Nitric Oxide(from 30 minutes to 8 hours post dose)
- Multiple Breath Nitrogen Washout(from 30 minutes to 8 hours post dose)
- Forced Expiratory Volume in the 1st second(from 30 minutes to 8 hours post dose)
研究者
研究点 (1)
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