Nasal Polyps
Conditions
Brief summary
Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal polyposis following sinus surgery. This project aims to further investigate that claim through a blinded randomized controlled clinical trial following patients who undergo functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly assigning participants to receive topical furosemide versus placebo nasal spray for 2 months post operatively. Outcomes would be compared at 6 months through endoscopic grading scores using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to measure the rate and degree of recurrence and impact on symptoms in the treatment group versus placebo.
Interventions
DRUGFurosemide
furosemide
DRUGPlacebo
placebo
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for functional endoscopic sinus surgery
Exclusion criteria
* Hypersensitivity to furosemide or sulfonamides * pregnancy * history of tinnitus * history of sensorineural hearing loss * poorly controlled diabetes * current diuretic therapy * known electrolyte disorder * currently taking aminoglycosides * BUN and creatinine levels out of the normal range * history of renal disease * allergy to sulfonamides
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polyp Recurrence | 6 months | Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Furosemide Furosemide: furosemide | 9 |
| Placebo Placebo: placebo | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Furosemide | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 1 / 9 | 3 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Polyp Recurrence
Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.
Time frame: 6 months
Population: This data was not collected and therefore no data analysis was done due to the study being terminated early secondary to 1) low enrollment due to the emergence of better medical alternatives to treat polyps (ie. Biologics) which made using furosemide not useful and 2) COVID.
Primary
Polyp Recurrence
Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.
Time frame: 6 months
Population: This data was not collected and therefore no data analysis was done due to the study being terminated early secondary to 1) low enrollment due to the emergence of better medical alternatives to treat polyps (ie. Biologics) which made using furosemide not useful and 2) COVID.
Primary
Polyp Recurrence
Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.
Time frame: 6 months
Population: This data was not collected and therefore no data analysis was done due to the study being terminated early secondary to 1) low enrollment due to the emergence of better medical alternatives to treat polyps (ie. Biologics) which made using furosemide not useful and 2) COVID.