Aerosol Inhalation Treatment for Dyspnea - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01440764

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:

MedlinePlus related topics: Breathing Problems

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 40mg 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: Capucine Morelot-Panzini, MD PhD	617 667 0572	cmorelot@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: Capucine Morelot-Panzini, MD PhD 617-667-0572 cmorelot@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:	September 26, 2011
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, 2012