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Aerosol Inhalation Treatment for Dyspnea - Patients

Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyspnea

Intervention: Furosemide (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Robert Banzett, PhD, Principal Investigator, Affiliation: Beth Israel Deaconess Hospital

Overall contact:
Victoria Molina, Phone: 617-667-0572, Email: vmolina1@bidmc.harvard.edu

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.

Clinical Details

Official title: Aerosol Inhalation Treatment for Dyspnea

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Subject rating of Breathing Discomfort (dyspnea)

Secondary outcome:

Multidimensional Dyspnea Profile - composite questionnaire

Urine output - mL

Detailed 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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Victoria Molina, Phone: 617-667-0572, Email: vmolina1@bidmc.harvard.edu

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Victoria Molina, Phone: 617-667-0572, Email: vmolina1@bidmc.harvard.edu
Dora Huang, Phone: 617 667 0572, Email: dhuang4@bidmc.harvard.edu
Additional Information

Related publications:

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.

Starting date: November 2014
Last updated: August 13, 2015

Page last updated: August 23, 2015

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