Aerosol Inhalation Treatment for Dyspnea

NCT ID: NCT01440764

Last Updated: 2017-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies.

Conditions

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Healthy Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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F(40), then Saline, then IV.F

On 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.

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

IV.F, then F(40), then Saline

On 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.

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

Saline, then F(40), then IV.F

On 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.

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

F(80), then Saline, then Saline

On 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.

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

Saline, then F(80), then Saline

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 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.

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

Interventions

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Furosemide

Intervention Type DRUG

Saline

Intervention Type DRUG

Other Intervention Names

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Lasix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Robert Banzett

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert B Banzett, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Hospital

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21778294 (View on PubMed)

Other Identifiers

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R01NR012009

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-P-000027/1

Identifier Type: -

Identifier Source: org_study_id

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