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Trial record 69 of 242 for:    furosemide

Aerosol Inhalation Treatment for Dyspnea - Patients

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ClinicalTrials.gov Identifier: NCT02524054
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : October 13, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Robert Banzett, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Dyspnea
Interventions Drug: Furosemide
Drug: Aerosolized saline
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Arm F Experimental: Aerosol Furosemide Study 2b Arm S
Hide Arm/Group Description Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration. Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours. Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
Period Title: Overall Study
Started 7 9 8
Completed 7 9 8
Not Completed 0 0 0
Arm/Group Title Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Total
Hide Arm/Group Description Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration. Inhalation of furosemide aerosol or placebo saline aerosol over the course of 10-15 min. Single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized. Total of all reporting groups
Overall Number of Baseline Participants 7 17 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 17 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  42.9%
5
  29.4%
8
  33.3%
>=65 years
4
  57.1%
12
  70.6%
16
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 17 participants 24 participants
69.14  (11.09) 67.41  (11.41) 67.92  (11.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 17 participants 24 participants
Female
3
  42.9%
4
  23.5%
7
  29.2%
Male
4
  57.1%
13
  76.5%
17
  70.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 17 participants 24 participants
Hispanic or Latino
0
   0.0%
1
   5.9%
1
   4.2%
Not Hispanic or Latino
7
 100.0%
16
  94.1%
23
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 17 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
4
  23.5%
5
  20.8%
White
6
  85.7%
13
  76.5%
19
  79.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 17 participants 24 participants
7 17 24
1.Primary Outcome
Title Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.
Hide Description

Subjects will rate breathing discomfort (dyspnea) during a 15 min exercise test using a visual analog scale before and after drug (or placebo) intervention. The treatment effect was measured as the rating of breathing discomfort rating before treatment minus the rating of breathing discomfort after treatment at equivalent work intensities.

Outcome Measure Time Frame: subjects performed arm exercise to induce dyspnea for approximately 15 min before and after aerosol inhalation. the average number of minutes between end of drug administration and post-intervention breathing discomfort rating:

Aerosol furosemide Study 2a arm: 38.7 minutes; Aerosol furosemide Study 2b arm: 21.8 minutes; Aerosol saline Study 2b arm: 21.3 minutes

Time Frame 15 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Aerosol Saline Study 2b
Hide Arm/Group Description:
Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
Inhalation of furosemide aerosol. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
Inhalation of saline aerosol . Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
Overall Number of Participants Analyzed 7 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.86  (2.31) -0.61  (1.61) -0.15  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aerosol Furosemide Study 2b, Aerosol Saline Study 2b
Comments This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Urine Output - mL
Hide Description

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

Following intervention, study team will measure urine output (mL). Study team will then rehydrate subject with an equal amount of liquid to their output.

Time Frame Summation of total urine output (mL) at 1 hour following drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
The 17 participants in 'Aerosol furosemide Study 2b' and 'Aerosol saline Study 2b' are the results from the same 17 subjects on two different test days.
Arm/Group Title Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Aerosol Saline Study 2b
Hide Arm/Group Description:
Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.

Inhalation of furosemide aerosol over the course of 10-15 min.

Across the study 2b, these subjects experienced a single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.

Inhalation of placebo saline aerosol over the course of 10-15 min.

Across the study 2b, these subjects experienced a single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.

Overall Number of Participants Analyzed 7 17 17
Mean (Standard Deviation)
Unit of Measure: ml of urine
189.8  (236.2) 573.6  (237.8) 63.9  (93.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aerosol Furosemide Study 2b, Aerosol Saline Study 2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Aerosol Saline Study 2b
Hide Arm/Group Description Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration. Inhalation of furosemide aerosol over the course of 10-15 min. Single administration of furosemide aerosol on one treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized. Inhalation of placebo saline aerosol over the course of 10-15 min. Single administration of saline aerosol. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
All-Cause Mortality
Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Aerosol Saline Study 2b
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Aerosol Saline Study 2b
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aerosol Furosemide Study 2a Aerosol Furosemide Study 2b Aerosol Saline Study 2b
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Banzett, PhD
Organization: Beth Israel Deaconess Medical Center
Phone: 6176670572
EMail: rbanzett@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Robert Banzett, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02524054     History of Changes
Other Study ID Numbers: 2011P000027
R01NR012009 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2015
First Posted: August 14, 2015
Results First Submitted: June 14, 2017
Results First Posted: October 13, 2017
Last Update Posted: January 23, 2018