Trial Outcomes & Findings for Aerosol Inhalation Treatment for Dyspnea - Patients (NCT NCT02524054)

Last Updated: 2018-01-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

15 min

Results posted on

2018-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Aerosol Furosemide Study 2a Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.	Aerosol Furosemide Study 2b Arm F 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.	Experimental: Aerosol Furosemide Study 2b Arm S 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.
Overall Study STARTED	7	9	8
Overall Study COMPLETED	7	9	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aerosol Inhalation Treatment for Dyspnea - Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerosol Furosemide Study 2a n=7 Participants Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.	Aerosol Furosemide Study 2b n=17 Participants 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 n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	69.14 years STANDARD_DEVIATION 11.09 • n=5 Participants	67.41 years STANDARD_DEVIATION 11.41 • n=7 Participants	67.92 years STANDARD_DEVIATION 11.34 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	17 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 min

Outcome measures

Outcome measures
Measure	Aerosol Furosemide Study 2a n=7 Participants Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.	Aerosol Furosemide Study 2b n=17 Participants 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.	Aerosol Saline Study 2b n=17 Participants 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.
Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.	-1.86 units on a scale Standard Deviation 2.31	-0.61 units on a scale Standard Deviation 1.61	-0.15 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Summation of total urine output (mL) at 1 hour following drug administration.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Aerosol Furosemide Study 2a n=7 Participants Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.	Aerosol Furosemide Study 2b n=17 Participants 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.	Aerosol Saline Study 2b n=17 Participants 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.
Urine Output - mL	189.8 ml of urine Standard Deviation 236.2	573.6 ml of urine Standard Deviation 237.8	63.9 ml of urine Standard Deviation 93.9

Adverse Events

Aerosol Furosemide Study 2a

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerosol Furosemide Study 2b

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerosol Saline Study 2b

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Banzett, PhD

Beth Israel Deaconess Medical Center

Phone: 6176670572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place