Aerosol Inhalation Treatment for Dyspnea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subject Rating of Breathing Discomfort (Dyspnea)
研究概览
简要总结
The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.
详细描述
This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Unstable heart or circulation disease
- •Seizure disorder
- •Severe migraine headaches
- •Liver or kidney disease
- •Adrenal gland problem (Pheochromocytoma)
- •Nerve problems that may affect your breathing sensation
- •Brain cancer
- •Drug or alcohol problem
- •Systemic lupus erythematosis (SLE)
- •High levels of depression, panic disorder, or other significant mental health problems
- •Serious ongoing pain
- •Under 18 years old
- •Not Fluent in English
研究组 & 干预措施
F(40), then Saline, then IV.F
On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
干预措施: Furosemide (Drug)
F(40), then Saline, then IV.F
On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
干预措施: Saline (Drug)
IV.F, then F(40), then Saline
On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
干预措施: Furosemide (Drug)
IV.F, then F(40), then Saline
On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
干预措施: Saline (Drug)
Saline, then F(40), then IV.F
On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 3), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
干预措施: Furosemide (Drug)
Saline, then F(40), then IV.F
On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 3), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
干预措施: Saline (Drug)
F(80), then Saline, then Saline
On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
干预措施: Furosemide (Drug)
F(80), then Saline, then Saline
On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
干预措施: Saline (Drug)
Saline, then F(80), then Saline
On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
干预措施: Furosemide (Drug)
Saline, then F(80), then Saline
On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
干预措施: Saline (Drug)
Saline, then Saline, then F(80)
On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
干预措施: Furosemide (Drug)
Saline, then Saline, then F(80)
On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
干预措施: Saline (Drug)
结局指标
主要结局
Subject Rating of Breathing Discomfort (Dyspnea)
时间窗: The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.
Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale. The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea. The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.
次要结局
- Multidimensional Dyspnea Profile(Measured before intervention)
- Urine Output(Cumulative urine output 1 hour after intervention)
研究者
Robert Banzett
Associate Professor of Medicine
Beth Israel Deaconess Medical Center