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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02524054
Other study ID # 2011P000027
Secondary ID R01NR012009
Status Completed
Phase Phase 1/Phase 2
First received May 5, 2015
Last updated December 21, 2017
Start date November 1, 2014
Est. completion date December 1, 2017

Study information

Verified date December 2017
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 1, 2017
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Urine Output - mL 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.
Summation of total urine output (mL) at 1 hour following drug administration.
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