Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03362515
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 78
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Polyps	Drug: Furosemide; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Furosemide	Drug: Furosemide; furosemide
Placebo Comparator: Placebo	Drug: Placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Polyp Recurrence [6 months]

   Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.

2. Polyp Recurrence [6 months]

   Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.

3. Polyp Recurrence [6 months]

   Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Department of Otolaryngology	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT03362515
• Other Study ID Numbers: 17D.264
• First Posted: Dec 5, 2017
• Last Update Posted: Apr 6, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Nasal Polyps; Furosemide

Study Results

No Results Posted as of Apr 6, 2021