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
- Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.
研究概览
简要总结
The purpose of this protocol is to develop and test aerosol furosemide, as 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 the second study in a series of studies investigating the treatment effect of aerosolized furosemide on hospitalized patients and outpatients with intractable dyspnea. The study will focus on patients who experience intractable dyspnea at rest or with minimal activity, e.g., dressing, bathing, cooking, or walking stairs or short distances.
There are two parts to this study: Study 2a is a pilot study on 5-10 patients. These trials are not blinded or placebo controlled; the investigators will use them to discover practical problems, and take the information back to the laboratory to develop solutions. We enrolled 7 subjects for Study 2a.
Study 2b will a randomized, placebo - controlled, double- blind study on 25 - 40 patients. The two planned treatments will be aerosolized furosemide and aerosolized saline, and will be given to each patient on two separate days. We failed to reach our enrollment goal, and ultimately enrolled 17 subjects for participation in Study 2b.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Intractable dyspnea at rest or with minimal activity
排除标准
- •Chronic congestive heart failure
- •Liver or kidney disease
- •Systemic lupus erythematosis (SLE)
- •Receiving potassium supplementation or other indication of hypokalemia
- •Major psychiatric disorders
- •Furosemide hypersensitivity
- •Not mentally competent and/or alert (unable to grant informed consent)
- •Under 18 years old
- •Not fluent in English
- •Inadequate birth control
研究组 & 干预措施
Aerosol furosemide Study 2a
Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
干预措施: Furosemide (Drug)
Aerosol furosemide Study 2b Arm F
Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
干预措施: Furosemide (Drug)
Aerosol furosemide Study 2b Arm F
Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
干预措施: Aerosolized saline (Drug)
Aerosol furosemide Study 2b Arm S
Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
干预措施: Furosemide (Drug)
Aerosol furosemide Study 2b Arm S
Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
干预措施: Aerosolized saline (Drug)
结局指标
主要结局
Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.
时间窗: 15 min
Subjects will rate breathing discomfort (dyspnea) during a 15 min exercise test using a visual analog scale before and after drug (or placebo) intervention. The treatment effect was measured as the rating of breathing discomfort rating before treatment minus the rating of breathing discomfort after treatment at equivalent work intensities. Outcome Measure Time Frame: subjects performed arm exercise to induce dyspnea for approximately 15 min before and after aerosol inhalation. the average number of minutes between end of drug administration and post-intervention breathing discomfort rating: Aerosol furosemide Study 2a arm: 38.7 minutes; Aerosol furosemide Study 2b arm: 21.8 minutes; Aerosol saline Study 2b arm: 21.3 minutes
次要结局
- Urine Output - mL(Summation of total urine output (mL) at 1 hour following drug administration.)
研究者
Robert Banzett
Associate Professor of Medicine
Beth Israel Deaconess Medical Center