Aerosol Inhalation Treatment for Dyspnea - Patients

NCT02524054 | Completed Phase 1 Results

• 2 other identifiers: 2011P000027R01NR012009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

Conditions

Dyspnea

Keywords

Dyspnea; Hospitalized patients; Ambulatory outpatients; Shortness of breath; Chronic obstructive pulmonary disease; Pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.

  Subjects will rate breathing discomfort (dyspnea) during a 15 min exercise test using a visual analog scale before and after drug (or placebo) intervention. The treatment effect was measured as the rating of breathing discomfort rating before treatment minus the rating of breathing discomfort after treatment at equivalent work intensities. Outcome Measure Time Frame: subjects performed arm exercise to induce dyspnea for approximately 15 min before and after aerosol inhalation. the average number of minutes between end of drug administration and post-intervention breathing discomfort rating: Aerosol furosemide Study 2a arm: 38.7 minutes; Aerosol furosemide Study 2b arm: 21.8 minutes; Aerosol saline Study 2b arm: 21.3 minutes

  15 min

Secondary Outcomes (1)

• Urine Output - mL

  Summation of total urine output (mL) at 1 hour following drug administration.

Study Arms (3)

Aerosol furosemide Study 2a

EXPERIMENTAL

Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.

Drug: Furosemide

Aerosol furosemide Study 2b Arm F

EXPERIMENTAL

Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.

Drug: Furosemide; Drug: Aerosolized saline

Aerosol furosemide Study 2b Arm S

EXPERIMENTAL

Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.

Drug: Furosemide; Drug: Aerosolized saline

Interventions

Furosemide DRUG

80 mg of Furosemide in 8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume.

Also known as: Lasix

Aerosol furosemide Study 2a; Aerosol furosemide Study 2b Arm F; Aerosol furosemide Study 2b Arm S

Aerosolized saline DRUG

8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume.

Also known as: Placebo

Aerosol furosemide Study 2b Arm F; Aerosol furosemide Study 2b Arm S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intractable dyspnea at rest or with minimal activity

You may not qualify if:

• Chronic congestive heart failure
• Liver or kidney disease
• Systemic lupus erythematosis (SLE)
• Receiving potassium supplementation or other indication of hypokalemia
• Major psychiatric disorders
• Furosemide hypersensitivity
• Not mentally competent and/or alert (unable to grant informed consent)
• Under 18 years old
• Not fluent in English
• Inadequate birth control

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related 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. Epub 2011 Jul 21.

  PMID: 21778294 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Robert Banzett, PhD
• Organization: Beth Israel Deaconess Medical Center

rbanzett@bidmc.harvard.edu

6176670572

Study Officials

• Robert Banzett, PhD

  Beth Israel Deaconess Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: August 14, 2015
• Study Start: November 1, 2014
• Primary Completion: November 30, 2016
• Study Completion: December 1, 2017
• Last Updated: January 23, 2018
• Results First Posted: October 13, 2017

Record last verified: 2017-12

Locations

US (1)