Aerosol Inhalation Treatment for Dyspnea
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Aerosol Inhalation Treatment for Dyspnea|
- Subject rating of Breathing Discomfort (dyspnea) [ Time Frame: repeated measurement for 2 hours from intervention ] [ Designated as safety issue: No ]Subjects will rate breathing discomfort (dyspnea) using a visual analog scale before and after intervention
- Multidimensional Dyspnea Profile [ Time Frame: repeated for 2 hours after intervention ] [ Designated as safety issue: No ]
- Urine output [ Time Frame: repeated measures for 2 hours after intervention ] [ Designated as safety issue: Yes ]diuresis is an expected effect of furosemide. to the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment
|Study Start Date:||September 2011|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Experimental: Aerosol furosemide||
Subjects will inhale 80mg of furosemide aerosol over the course of 5-10 min. There will be a single administration of aerosol furosemide and either aerosol albuterol or aerosol saline in each subject, as well as an IV furosemide dose to control for systemic effects. Each intervention will occur on a separate day.
Other Name: Lasix
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440764
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Robert B Banzett, PhD||Beth Israel Deaconess Hospital|