Aerosol Inhalation Treatment for Dyspnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01440764
First received: September 23, 2011
Last updated: August 7, 2014
Last verified: August 2014
  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:


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: 32
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440764

Contacts
Contact: Victoria Molina 617-667-0572 vmolina1@bidmc.harvard.edu
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: Victoria Molina    617-667-0572    vmolina1@bidmc.harvard.edu   
Contact: Dora Huang    617 667 0572    dhuang4@bidmc.harvard.edu   
Principal Investigator: Robert B Banzett, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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.

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: August 7, 2014
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
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014