Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Nasal Polyps Clinical Trial

Official title:

Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03362515
• Other study ID #: 17D.264
• Status: Terminated
• Phase: Phase 2
• Start date: December 1, 2017
• Est. completion date: April 14, 2022

Study information

• Verified date: August 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasal Polyps

Intervention

Drug:
• Furosemide
furosemide
• Placebo
placebo

Locations

Country	Name	City	State
United States	Thomas Jefferson University Department of Otolaryngology	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyp Recurrence	Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.	6 months
Primary	Polyp Recurrence	Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.	6 months
Primary	Polyp Recurrence	Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.	6 months