Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Study 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. 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.


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


NCT ID:

NCT02524054


Primary Contact:

Principal Investigator
Robert Banzett, PhD
Beth Israel Deaconess Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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