- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440764
Aerosol Inhalation Treatment for Dyspnea
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Other Names:
|
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. |
Other Names:
|
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. |
Other Names:
|
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. |
Other Names:
|
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. |
Other Names:
|
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. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured before intervention
|
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
|
Cumulative urine output 1 hour after intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert B Banzett, PhD, Beth Israel Deaconess Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-P-000027/1
- R01NR012009 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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