Aerosol Inhalation Treatment for Dyspnea - Patients



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/24/2018
Start Date:November 1, 2014
End Date:December 1, 2017

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Aerosol Inhalation Treatment for Dyspnea

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.

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.

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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-0572
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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