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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR012009 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.
This is the second study in a series of studies investigating the treatment effect of aerosolized furosemide on hospitalized patients and outpatients with intractable dyspnea. The study will focus on patients who experience intractable dyspnea at rest or with minimal activity, e.g., dressing, bathing, cooking, or walking stairs or short distances.
There are two parts to this study: Study 2a is a pilot study on 5-10 patients. These trials are not blinded or placebo controlled; the investigators will use them to discover practical problems, and take the information back to the laboratory to develop solutions. We enrolled 7 subjects for Study 2a.
Study 2b will a randomized, placebo - controlled, double- blind study on 25 - 40 patients. The two planned treatments will be aerosolized furosemide and aerosolized saline, and will be given to each patient on two separate days. We failed to reach our enrollment goal, and ultimately enrolled 17 subjects for participation in Study 2b.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosol furosemide Study 2a | Experimental | 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 | Experimental | 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. |
|
| Aerosol furosemide Study 2b Arm S | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | 80 mg of Furosemide in 8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment. | 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 | 15 min |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Output - mL | 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. | Summation of total urine output (mL) at 1 hour following drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Banzett, PhD | Beth Israel Deaconess Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21778294 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Aerosol Furosemide Study 2b |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment. | 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 | Posted | Mean | Standard Deviation | units on a scale | 15 min |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Banzett, PhD | Beth Israel Deaconess Medical Center | 6176670572 | rbanzett@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Aerosolized saline | Drug | 8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume. |
|
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Aerosol Furosemide Study 2b | 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. |
| OG002 | Aerosol Saline Study 2b | 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. |
|
|
|
| Secondary | Urine Output - mL | 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. | 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. | Posted | Mean | Standard Deviation | ml of urine | Summation of total urine output (mL) at 1 hour following drug administration. |
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|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Aerosol Furosemide Study 2b | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Aerosol Saline Study 2b | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |