The Role of Endorphins in the Perception of Dyspnea With Resistive Loading in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Intensity of Breathlessness
研究概览
简要总结
Endorphins are released in response to breathing difficulty and can modify the perception of breathlessness. In this randomized placebo-controlled trial, resistive breathing loads are used to provoke breathlessness in patients with chronic obstructive pulmonary disease. The hypothesis of the study is that intravenous (IV) administration of naloxone, a medication which blocks endorphin activity, will increase the perception of breathlessness experienced by patients while breathing through a resistance device, compared with IV administration of normal saline.
详细描述
Study Design:
The study is a randomized, double-blind, placebo-controlled investigation comparing the intravenous administration of:
- normal saline, considered a placebo, is expected to have no effect on patient ratings of dyspnea.
- naloxone, an opioid receptor antagonist with penetration into the central nervous system and blocks the effect of beta-endorphins, is expected to increase ratings of dyspnea in patients with COPD.
Dyspnea will be induced by resistive load breathing for a minimum of 10 minutes.
Subjects:
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient 50 years of age or older;
- •A diagnosis of COPD defined by American Thoracic Society-European Respiratory Society criteria
- •Current or former smoker with a smoking history of greater than or equal to 10 pack-years;
- •A post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted; AND
- •A post-bronchodilator FEV1/forced vital capacity ratio less than 70%; and clinically stable COPD.
排除标准
- •Any patient who has a concomitant disease that might interfere with study procedures or evaluation;
- •Inability to perform resistive breathing maneuvers; OR
- •Any current use of a narcotic medication.
研究组 & 干预措施
naloxone
干预措施: naloxone (Drug)
normal saline
干预措施: normal saline (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)
The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline. 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)
The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline. Subject rating of intensity of unpleasantness was obtained 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
- Change in Level of B-endorphin Immunoreactivity During Saline Intervention(Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization)
- Endurance Time(Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7))
- Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention(Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization)