Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Phase 2

Terminated

• Conditions: Nasal Polyps
• Interventions: Drug: Placebo; Drug: Furosemide

• Registration Number: NCT03362515
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-05
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Results First Submitted: 2023-06-07
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Results First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Furosemide	Furosemide	-

Primary Outcome Measures

Name	Time	Method
Polyp Recurrence	6 months	Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.

Trial Locations

Locations (1)

Thomas Jefferson University Department of Otolaryngology; 🇺🇸 Philadelphia, Pennsylvania, United States