Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Primary Purpose
Nasal Polyps
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Polyps
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University Department of Otolaryngology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Furosemide
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Polyp Recurrence
Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.
Polyp Recurrence
Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.
Polyp Recurrence
Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT03362515
First Posted
November 28, 2017
Last Updated
August 4, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03362515
Brief Title
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Official Title
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated prematurely due to low enrollment numbers and the development of better drugs to treat polyps (ie. Biologics) which were not available when the study began.
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Furosemide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
furosemide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Polyp Recurrence
Description
Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.
Time Frame
6 months
Title
Polyp Recurrence
Description
Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.
Time Frame
6 months
Title
Polyp Recurrence
Description
Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Thomas Jefferson University Department of Otolaryngology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
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