Aerosol Inhalation Treatment for Dyspnea

Healthy Clinical Trial

Official title:

Aerosol Inhalation Treatment for Dyspnea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01440764
• Other study ID #: 2011-P-000027/1
• Secondary ID: R01NR012009
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: September 23, 2011
• Last updated: March 6, 2017
• Start date: September 2011
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Healthy

Intervention

Drug:
• Furosemide

• Saline

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Oct 15;184(8):920-7. doi: 10.1164/rccm.201101-0005OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject rating of Breathing Discomfort (dyspnea)	Subjects will rate breathing discomfort (dyspnea) using a visual analog scale before and after intervention	repeated measurement for 2 hours from intervention
Secondary	Multidimensional Dyspnea Profile		repeated for 2 hours after intervention
Secondary	Urine output	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	repeated measures for 2 hours after intervention