The Role of Substance P on Perception of Breathlessness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Intensity of Breathlessness
研究概览
简要总结
Substance P is released from sensory nerves and transmits pain information into the central nervous system. As pain and dyspnea share many characteristics, including similar neurological pathways, it is possible that substance P may contribute to the sensation of dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary disease (COPD) will provide lower ratings of breathlessness during resistive load breathing with oral aprepitant, a medication that blocks the activity of substance P, compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years of age or older
- •diagnosis of COPD
- •former smoker > 10 pack-years
- •clinical diagnosis of chronic bronchitis
- •post-bronchodilator forced expiratory volume in one second (FEV1) 30 - 80% predicted
- •FEV1/forced vital capacity ratio less than or equal to 70%
排除标准
- •current smoker
- •pregnant women
- •concomitant disease that might interfere with study procedures
- •peripheral vascular disease or cold hypersensitivity
- •drugs that might interfere with aprepitant
研究组 & 干预措施
aprepitant
干预措施: aprepitant (Drug)
inert powder
干预措施: placebo (Drug)
结局指标
主要结局
Intensity of Breathlessness
时间窗: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
Time-weighted averages of intensity of breathlessness. Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Intensity" and at the top by "Greatest Intensity".
Unpleasantness of Breathlessness
时间窗: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
Time-weighted averages of unpleasantness of breathlessness. Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Unpleasantness" and at the top by "Greatest Unpleasantness".
次要结局
- Intensity of Pain(Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7))