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Aerosol Inhalation Treatment for Dyspnea

This study is currently recruiting participants.
Verified March 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01440764
First received: September 23, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Healthy
Dyspnea
 Drug: Furosemide
 Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Furosemide
U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: September 2011
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerosol furosemide Drug: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440764

Contacts
Contact: Heather Bernstein 617-667-0572 hbernste@caregroup.org
Contact: Carl O'Donnell, PhD 617-667-0572 codonne1@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Heather Bernstein     617-667-0572     hbernste@caregroup.org    
Principal Investigator: Robert B Banzett, PhD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Robert B Banzett, PhD Beth Israel Deaconess Hospital
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01440764     History of Changes
Other Study ID Numbers: 2011-P-000027/1, R01NR012009
Study First Received: September 23, 2011
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Beth Israel Deaconess Committee on Clinical Investigations (IRB)

Keywords provided by Beth Israel Deaconess Medical Center:
dyspnea
Laboratory model of dyspnea in healthy subjects

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013