HealthyPhase 1/2NCT01440764

Aerosol Inhalation Treatment for Dyspnea

A Phase 1/2 study testing Furosemide and Saline in people with Healthy and Dyspnea, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, 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 olderHealthy volunteers can take part
Conditions the study is for: Healthy, Dyspnea
What is being tested?: Furosemide and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Apr 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy

Who cannot join

Unstable heart or circulation disease
Stroke
Seizure disorder
Severe migraine headaches
Liver or kidney disease
Adrenal gland problem (Pheochromocytoma)

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Read the detailed description

This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies.

Conditions: Healthy, Dyspnea
Being tested: Furosemide, Saline
Keywords: dyspnea, Laboratory model of dyspnea in healthy subjects
Medical subject headings: Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FurosemideDrug
Also called Lasix
SalineDrug

Study groups in NCT01440764
Study group	Role	What they receive
F(40), then Saline, then IV.F	Experimental	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. Receives: Drug: Furosemide; Drug: Saline
IV.F, then F(40), then Saline	Experimental	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. Receives: Drug: Furosemide; Drug: Saline
Saline, then F(40), then IV.F	Experimental	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. Receives: Drug: Furosemide; Drug: Saline
F(80), then Saline, then Saline	Experimental	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. Receives: Drug: Furosemide; Drug: Saline
Saline, then F(80), then Saline	Experimental	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. Receives: Drug: Furosemide; Drug: Saline
Saline, then Saline, then F(80)	Experimental	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. Receives: Drug: Furosemide; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Subject Rating of Breathing Discomfort (Dyspnea)
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.
Measured: 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 outcomes (2)

Multidimensional Dyspnea Profile
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: Measured before intervention
Urine Output
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
Measured: Cumulative urine output 1 hour after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Apr 2017

First posted27 Sep 2011 (estimated)
Study startSep 2011
Primary completionApr 2016
Study completionApr 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 HealthyStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01440764
Sponsor's protocol ID: 2011-P-000027/1
Other IDs: R01NR012009
Status last verified: May 2017
First submitted: 23 Sep 2011
Last updated: 14 Jun 2017
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aerosol Inhalation Treatment for Dyspnea
ClinicalTrials.gov ID: NCT01440764
Acronym / sponsor ID: 2011-P-000027/1
Conditions: Healthy, Dyspnea
Keywords: dyspnea, Laboratory model of dyspnea in healthy subjects
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: Sep 2011
Primary completion: Apr 2016 (actual)
Study completion: Apr 2017 (actual)
First posted: 27 Sep 2011 (estimated)
Results: Posted 14 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
F(40), then Saline, then IV.F	Experimental	Drug: Furosemide, Drug: SalineOn 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.
IV.F, then F(40), then Saline	Experimental	Drug: Furosemide, Drug: SalineOn 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.
Saline, then F(40), then IV.F	Experimental	Drug: Furosemide, Drug: SalineOn 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.
F(80), then Saline, then Saline	Experimental	Drug: Furosemide, Drug: SalineOn 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.
Saline, then F(80), then Saline	Experimental	Drug: Furosemide, Drug: SalineOn 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.
Saline, then Saline, then F(80)	Experimental	Drug: Furosemide, Drug: SalineOn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy

Key exclusion criteria (15 listed)

Unstable heart or circulation disease
Stroke
Seizure disorder
Severe migraine headaches
Liver or kidney disease

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: Lasix	Drug	F(40), then Saline, then IV.F, F(80), then Saline, then Saline, IV.F, then F(40), then Saline, Saline, then F(40), then IV.F, Saline, then F(80), then Saline, Saline, then Saline, then F(80)
Saline	Drug	F(40), then Saline, then IV.F, F(80), then Saline, then Saline, IV.F, then F(40), then Saline, Saline, then F(40), then IV.F, Saline, then F(80), then Saline, Saline, then Saline, then F(80)

Primary outcome

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.

2 secondary outcomes

Multidimensional Dyspnea Profile
Time frame: Measured before intervention
Urine Output
Time frame: Cumulative urine output 1 hour after intervention

Results and safety

Results posted to the registry on 14 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
F(40), Then Saline, Then IV.F	4	4
IV.F, Then F(40), Then Saline	2	2
Saline, Then F(40), Then IV.F	6	6
Saline, Then F(80), Then IV.F	1	1
F(80), Then Saline, Then Saline	3	3
Saline, Then F(80), Then Saline	5	5
Saline, Then Saline, Then F(80)	3	3

Primary outcome: 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.. Mean (Standard Error). Unit: units on a scale

Measure	Aerosol Furosemide (40 mg) n = 11	Aerosol Saline (4 ml) n = 10	IV Furosemide n = 10	Aerosol Furosemide (80mg) n = 11	Aerosol Saline (8 ml) n = 11
Value	20 (13)	20 (10)	16 (13)	17 (3)	13 (4)

Aerosol Furosemide (40 mg) vs Aerosol Saline (4 ml): p = 0.99, t-test, 2 sided
Aerosol Furosemide (80mg) vs Aerosol Saline (8 ml): p = 0.32, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aerosol Furosemide (40 mg)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Aerosol Furosemide (80mg)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Aerosol Saline (4 ml)	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Aerosol Saline (8 ml)	0 of 12 (0%)	0 of 11 (0%)	0 of 12
IV Furosemide	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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 B 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 Saline in people with Healthy and 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 15 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 14 Jun 2017. 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 14 Jun 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?

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.). 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 NCT01440764, 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 14 Jun 2017.