Aerosol Inhalation Treatment for Dyspnea - Patients

NCT ID: NCT02524054

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2017-12-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: 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.

Aerosolized saline

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: 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.

Aerosolized saline

Intervention Type: 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.

Interventions

Furosemide

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.

Intervention Type: DRUG

Aerosolized saline

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.

Intervention Type: DRUG

Other Intervention Names

Lasix; Placebo

Eligibility Criteria

Inclusion Criteria

• Intractable dyspnea at rest or with minimal activity

Exclusion Criteria

• 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
• Not mentally competent and/or alert (unable to grant informed consent)
• Under 18 years old
• Not fluent in English
• Inadequate birth control

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert Banzett

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Banzett, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Hospital

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21778294 (View on PubMed)

Other Identifiers

R01NR012009

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011P000027

Identifier Type: -

Identifier Source: org_study_id