Aerosol Inhalation Treatment for Dyspnea

Beth Israel Lahey Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy; Dyspnea

Treatments: Drug: Furosemide; Drug: Saline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01440764

R01NR012009 (U.S. NIH Grant/Contract)

2011-P-000027/1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy

Exclusion criteria

• Unstable heart or circulation disease
• Stroke
• 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
• Pregnant
• Under 18 years old
• Not Fluent in English

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 6 patient groups

F(40), then Saline, then IV.F

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Furosemide

IV.F, then F(40), then Saline

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Furosemide

Saline, then F(40), then IV.F

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Furosemide

F(80), then Saline, then Saline

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Furosemide

Saline, then F(80), then Saline

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Furosemide

Saline, then Saline, then F(80)

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Furosemide