Phase 2
N=24
Aerosol Inhalation Treatment for Dyspnea - Patients
Dyspnea
Bottom Line
View on ClinicalTrials.gov: NCT02524054 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment. — -1.86; -0.61; -0.15 units on a scale — p=0.35
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Furosemide (Drug); Aerosolized saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment. |
-1.86; -0.61; -0.15 | 0.35 |
| SECONDARY Urine Output - mL |
189.8; 573.6; 63.9 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02524054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.