Aerosol Inhalation Treatment for Dyspnea - Patients

Dyspnea Clinical Trial

Official title:

Aerosol Inhalation Treatment for Dyspnea

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
• 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

Related Conditions & MeSH terms

• Dyspnea

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.