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 questionnaireUrine 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
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