Aerosol Inhalation Treatment for Dyspnea

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ClinicalTrials.gov Identifier: NCT01440764

Recruitment Status : Completed

First Posted : September 27, 2011

Results First Posted : June 14, 2017

Last Update Posted : June 14, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Institute of Nursing Research (NINR)

Information provided by (Responsible Party):

Robert Banzett, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy Dyspnea	Drug: Furosemide Drug: Saline	Phase 1 Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Aerosol Inhalation Treatment for Dyspnea
Study Start Date :	September 2011
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breathing Problems

Drug Information available for: Furosemide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Furosemide Other Name: Lasix Drug: Saline
Experimental: 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.	Drug: Furosemide Other Name: Lasix Drug: Saline
Experimental: 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.	Drug: Furosemide Other Name: Lasix Drug: Saline
Experimental: 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.	Drug: Furosemide Other Name: Lasix Drug: Saline
Experimental: 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.	Drug: Furosemide Other Name: Lasix Drug: Saline
Experimental: 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.	Drug: Furosemide Other Name: Lasix Drug: Saline

Outcome Measures

Primary Outcome Measures :

Subject Rating of Breathing Discomfort (Dyspnea) [ Time Frame: 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.

Secondary Outcome Measures :

Multidimensional Dyspnea Profile [ Time Frame: Measured before intervention ]
Characterization of subject's response to laboratory dyspnea model. Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis. Subjects were asked to complete the MDP with reference to the last 30 sec of each run. To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale. The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.
Urine Output [ Time Frame: Cumulative urine output 1 hour after intervention ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440764

Locations

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

National Institute of Nursing Research (NINR)

Investigators

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Principal Investigator:	Robert B Banzett, PhD	Beth Israel Deaconess Hospital

More Information

Publications:

Banzett RB, Adams L, O'Donnell CR, Gilman SA, Lansing RW, Schwartzstein RM. Using laboratory models to test treatment: morphine reduces dyspnea and hypercapnic ventilatory response. Am J Respir Crit Care Med. 2011 Oct 15;184(8):920-7. doi: 10.1164/rccm.201101-0005OC. Epub 2011 Jul 21.

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Responsible Party:	Robert Banzett, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01440764
Other Study ID Numbers:	2011-P-000027/1 R01NR012009 ( U.S. NIH Grant/Contract )
First Posted:	September 27, 2011 Key Record Dates
Results First Posted:	June 14, 2017
Last Update Posted:	June 14, 2017
Last Verified:	May 2017

Keywords provided by Robert Banzett, Beth Israel Deaconess Medical Center:


dyspnea Laboratory model of dyspnea in healthy subjects

Additional relevant MeSH terms:

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Dyspnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Furosemide Diuretics	Natriuretic Agents Physiological Effects of Drugs Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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