DyspneaPhase 1/2NCT02524054
Aerosol Inhalation Treatment for Dyspnea - Patients
A Phase 1/2 study testing Furosemide and Aerosolized saline in people with Dyspnea, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Furosemide and Aerosolized saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 1 Dec 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intractable dyspnea at rest or with minimal activity
Who cannot join
- Chronic congestive heart failure
- Liver or kidney disease
- Systemic lupus erythematosis (SLE)
- Receiving potassium supplementation or other indication of hypokalemia
- Major psychiatric disorders
- Furosemide hypersensitivity
Show all 10Show fewer
- Not mentally competent and/or alert (unable to grant informed consent)
- Under 18 years old
- Not fluent in English
- Inadequate birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Aerosol Inhalation Treatment for Dyspnea
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.
Read the detailed description
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.
- Conditions
- Dyspnea
- Being tested
- Furosemide, Aerosolized saline
- Keywords
- Dyspnea, Hospitalized patients, Ambulatory outpatients, Shortness of breath, Chronic obstructive pulmonary disease, Pulmonary disease
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Lasix
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.
Aerosolized salineDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Furosemide |
| 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. Receives: Drug: Furosemide; Drug: Aerosolized saline |
| 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. Receives: Drug: Furosemide; Drug: Aerosolized saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 min
Secondary outcomes (1)
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.
Measured: Summation of total urine output (mL) at 1 hour following drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start1 Nov 2014
- Primary completion30 Nov 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Robert Banzett, Beth Israel Deaconess Medical Center
- Investigators
- Robert Banzett, PhD, Principal investigator, Beth Israel Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524054
- Sponsor's protocol ID
- 2011P000027
- Other IDs
- R01NR012009
- Status last verified
- Dec 2017
- First submitted
- 5 May 2015
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 21778294
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosol Inhalation Treatment for Dyspnea
- ClinicalTrials.gov ID
- NCT02524054
- Acronym / sponsor ID
- 2011P000027
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Hospitalized patients, Ambulatory outpatients, Shortness of breath, Chronic obstructive pulmonary disease, Pulmonary disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerosol furosemide Study 2a | Experimental | Drug: FurosemideSubjects 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 | Drug: Furosemide, Drug: Aerosolized salineInhalation 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 | Drug: Furosemide, Drug: Aerosolized salineInhalation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intractable dyspnea at rest or with minimal activity
Key exclusion criteria (10 listed)
- Chronic congestive heart failure
- Liver or kidney disease
- Systemic lupus erythematosis (SLE)
- Receiving potassium supplementation or other indication of hypokalemia
- Major psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideAlso: Lasix80 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. | Drug | Aerosol furosemide Study 2a, Aerosol furosemide Study 2b Arm F, Aerosol furosemide Study 2b Arm S |
| Aerosolized salineAlso: Placebo8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume. | Drug | Aerosol furosemide Study 2b Arm F, Aerosol furosemide Study 2b Arm S |
Primary outcome
Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.
Time frame: 15 min
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
1 secondary outcome
Urine Output - mL
Time frame: Summation of total urine output (mL) at 1 hour following drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21778294Banzett 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Banzett, PhD principal investigator
Beth Israel Deaconess Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Furosemide and Aerosolized saline in people with Dyspnea, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment. (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.