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Aerosol Inhalation Treatment for Dyspnea

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ClinicalTrials.gov Identifier: NCT01440764
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Robert Banzett, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE September 23, 2011
First Posted Date  ICMJE September 27, 2011
Results First Submitted Date  ICMJE April 11, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
Subject Rating of Breathing Discomfort (Dyspnea) [ Time Frame: repeated measurement for 2 hours from intervention ]
Subjects will rate breathing discomfort (dyspnea) using a visual analog scale before and after intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
  • Multidimensional Dyspnea Profile [ Time Frame: repeated for 2 hours after intervention ]
  • Urine Output [ Time Frame: repeated measures for 2 hours 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerosol Inhalation Treatment for Dyspnea
Official Title  ICMJE Aerosol Inhalation Treatment for Dyspnea
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Dyspnea
Intervention  ICMJE
  • Drug: Furosemide
    Other Name: Lasix
  • Drug: Saline
Study Arms  ICMJE
  • Experimental: 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.

    Interventions:
    • Drug: Furosemide
    • Drug: Saline
  • Experimental: 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.

    Interventions:
    • Drug: Furosemide
    • Drug: Saline
  • Experimental: 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.

    Interventions:
    • Drug: Furosemide
    • Drug: Saline
  • Experimental: 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.

    Interventions:
    • Drug: Furosemide
    • Drug: Saline
  • Experimental: 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.

    Interventions:
    • Drug: Furosemide
    • Drug: Saline
  • Experimental: 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.

    Interventions:
    • Drug: Furosemide
    • Drug: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2011)
12
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01440764
Other Study ID Numbers  ICMJE 2011-P-000027/1
R01NR012009 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Banzett, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Robert B Banzett, PhD Beth Israel Deaconess Hospital
PRS Account Beth Israel Deaconess Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP