Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2022-04-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Furosemide

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

furosemide

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Furosemide

furosemide

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No