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Aerosol Inhalation Treatment for Dyspnea

This study is ongoing, but not recruiting participants.
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: July 21, 2016
Last verified: July 2016
  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
Drug: Saline
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


Enrollment: 15
Study Start Date: September 2011
Estimated Study Completion Date: October 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerosol Furosemide (40 mg)

Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.

To be compared to Aerosol Saline (4ml) Arm and IV Furosemide Arm.

Drug: Furosemide
Other Name: Lasix
Experimental: Aerosol Furosemide (80mg)

Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.

To be compared to Aerosol Saline (8ml) Arm.

Drug: Furosemide
Other Name: Lasix
Placebo Comparator: Aerosol Saline (4 ml)

Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.

To be compared to Aerosol Furosemide (40mg) Arm and IV Furosemide Arm.

Drug: Saline
Placebo Comparator: Aerosol Saline (8 ml)

Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.

To be compared to Aerosol Furosemide (80mg) Arm.

Drug: Saline
Active Comparator: IV Furosemide

Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.

To be compared to Aerosol Furosemide (40mg) Arm and Aerosol Saline (4 ml) Arm.

Drug: Furosemide
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   (Adult, Senior)
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

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

Publications:
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: July 21, 2016
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
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016