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Healthy | Aerosol Inhalation Treatment for Dyspnea

Healthy research study

What is the primary objective of this study?

The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

Who is eligible to participate?

Inclusion Criteria: - Healthy Exclusion Criteria: - Unstable heart or circulation disease - Stroke - Seizure disorder - Severe migraine headaches - Liver or kidney disease - Adrenal gland problem (Pheochromocytoma) - Nerve problems that may affect your breathing sensation - Brain cancer - Drug or alcohol problem - Systemic lupus erythematosis (SLE) - High levels of depression, panic disorder, or other significant mental health problems - Serious ongoing pain - Pregnant - Under 18 years old - Not Fluent in English

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Dyspnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Furosemide

Drug:Saline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

F(40), then Saline, then IV.FOn Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

IV.F, then F(40), then SalineOn Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.

Saline, then F(40), then IV.FOn Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 3), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

F(80), then Saline, then SalineOn Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

Saline, then F(80), then SalineOn Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

Saline, then Saline, then F(80)On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.

Study Status

Completed

Start Date: September 2011

Completed Date: April 2017

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Subject Rating of Breathing Discomfort (Dyspnea)

Secondary Outcome: Multidimensional Dyspnea Profile

Study sponsors, principal investigator, and references

Principal Investigator: Robert B Banzett, PhD

Lead Sponsor: Beth Israel Deaconess Medical Center

Collaborator: National Institute of Nursing Research (NINR)

More information:https://clinicaltrials.gov/show/NCT01440764

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.

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