Aerosol Inhalation Treatment for Dyspnea

May 18, 2017 updated by: Robert Banzett, Beth Israel Deaconess Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Saline
Drug: Furosemide
Other Names:
  • Lasix
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: Saline
Drug: Furosemide
Other Names:
  • Lasix
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: Saline
Drug: Furosemide
Other Names:
  • Lasix
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: Saline
Drug: Furosemide
Other Names:
  • Lasix
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: Saline
Drug: Furosemide
Other Names:
  • Lasix
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: Saline
Drug: Furosemide
Other Names:
  • Lasix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured before intervention
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
Cumulative urine output 1 hour after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institute of Nursing Research (NINR)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

September 26, 2011

First Posted (Estimate)

September 27, 2011

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-P-000027/1
  • R01NR012009 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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