Aerosol Inhalation Treatment for Dyspnea - Patients

Beth Israel Lahey Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dyspnea

Treatments: Drug: Furosemide; Drug: Aerosolized saline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02524054

R01NR012009 (U.S. NIH Grant/Contract)

2011P000027

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intractable dyspnea at rest or with minimal activity

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Aerosol furosemide Study 2a

Experimental group

Description:

Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.

Treatment:

Drug: Furosemide

Aerosol furosemide Study 2b Arm F

Experimental group

Description:

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.

Treatment:

Drug: Aerosolized saline

Drug: Furosemide

Aerosol furosemide Study 2b Arm S

Experimental group

Description:

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.

Treatment:

Drug: Aerosolized saline

Drug: Furosemide