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NCT Number: NCT01440764

Aerosol Inhalation Treatment for Dyspnea

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.

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Key information

Conditions

Healthy Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

Other names: Lasix

Saline

Drug

Primary outcomes

  1. Subject Rating of Breathing Discomfort (Dyspnea)

    Time frame: The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.

    Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale. The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea. The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.

Secondary outcomes

  1. Multidimensional Dyspnea Profile

    Time frame: Measured before intervention

    Characterization of subject's response to laboratory dyspnea model. Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis. Subjects were asked to complete the MDP with reference to the last 30 sec of each run. To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale. The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.

  2. Urine Output

    Time frame: Cumulative urine output 1 hour after intervention

    Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Sep 27, 2011
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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