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Aerosol Inhalation Treatment for Dyspnea - Patients

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ClinicalTrials.gov Identifier: NCT02524054
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : October 13, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Robert Banzett, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Dyspnea Drug: Furosemide Drug: Aerosolized saline Phase 1 Phase 2

Detailed Description:

This is the second study in a series of studies investigating the treatment effect of aerosolized furosemide on hospitalized patients and outpatients with intractable dyspnea. The study will focus on patients who experience intractable dyspnea at rest or with minimal activity, e.g., dressing, bathing, cooking, or walking stairs or short distances.

There are two parts to this study: Study 2a is a pilot study on 5-10 patients. These trials are not blinded or placebo controlled; the investigators will use them to discover practical problems, and take the information back to the laboratory to develop solutions. We enrolled 7 subjects for Study 2a.

Study 2b will a randomized, placebo - controlled, double- blind study on 25 - 40 patients. The two planned treatments will be aerosolized furosemide and aerosolized saline, and will be given to each patient on two separate days. We failed to reach our enrollment goal, and ultimately enrolled 17 subjects for participation in Study 2b.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Aerosol Inhalation Treatment for Dyspnea
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Aerosol furosemide Study 2a
Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
Drug: Furosemide
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.
Other Name: Lasix

Experimental: Aerosol furosemide Study 2b Arm F
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
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.
Other Name: Lasix

Drug: Aerosolized saline
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.
Other Name: Placebo

Experimental: Aerosol furosemide Study 2b Arm S
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
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.
Other Name: Lasix

Drug: Aerosolized saline
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.
Other Name: Placebo




Primary Outcome Measures :
  1. Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment. [ Time Frame: 15 min ]

    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



Secondary Outcome Measures :
  1. Urine Output - mL [ Time Frame: Summation of total urine output (mL) at 1 hour following drug administration. ]

    Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed in the blood, diuresis is an expected 'side effect' of this treatment.

    Following intervention, study team will measure urine output (mL). Study team will then rehydrate subject with an equal amount of liquid to their output.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intractable dyspnea at rest or with minimal activity

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524054


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

Publications:
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Responsible Party: Robert Banzett, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02524054     History of Changes
Other Study ID Numbers: 2011P000027
R01NR012009 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2015    Key Record Dates
Results First Posted: October 13, 2017
Last Update Posted: January 23, 2018
Last Verified: December 2017
Keywords provided by Robert Banzett, Beth Israel Deaconess Medical Center:
Dyspnea
Hospitalized patients
Ambulatory outpatients
Shortness of breath
Chronic obstructive pulmonary disease
Pulmonary disease
Additional relevant MeSH terms:
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Furosemide
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action