Clinical Trial: Aerosol Inhalation Treatment for Dyspnea - Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Aerosol Inhalation Treatment for Dyspnea

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.

Detailed Summary:

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.

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.

Current Primary Outcome: Subject rating of Breathing Discomfort (dyspnea) [ Time Frame: Repeated measurement for 2 hours from intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Multidimensional Dyspnea Profile - composite questionnaire [ Time Frame: 10-20 minutes prior to and following intervention ]
  Subjects will fill out Multidimensional Dyspnea Profile, a composite questionnaire which has the subject rate their breathing discomfort (dyspnea) using a visual analog scale. The questionnaire will also ask the subjects to choose physical descriptors of their breathing discomfort, and rate those descriptions using visual analog scales. Lastly, the subjects will rate emotions they might have been feeling while they are short of breath using a visual analog scale.
• Urine output - mL [ Time Frame: Repeated measures for 2 hours after intervention ]

  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.

Original Secondary Outcome: Same as current

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: May 5, 2015
Date Started: November 2014
Date Completion: August 2017
Last Updated: March 6, 2017
Last Verified: March 2017