Clinical trial NCT02524054: Aerosol Inhalation Treatment for Dyspnea - Patients
Official title: Aerosol Inhalation Treatment for Dyspnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dyspnea
Keywords: Dyspnea
Hospitalized patients
Ambulatory outpatients
Shortness of breath
Chronic obstructive pulmonary disease
Pulmonary disease
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2015-08-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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. 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.

Eligibility 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

Primary outcomes:
measure: Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.
timeFrame: 15 min
Secondary outcomes:
measure: Urine Output - mL
timeFrame: Summation of total urine output (mL) at 1 hour following drug administration.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Hospital
name: Robert Banzett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.