Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

NCT03362515 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 17D.264
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Polyps

Outcome Measures

Primary Outcomes (3)

• Polyp Recurrence

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

  6 months

• Polyp Recurrence

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

  6 months

• Polyp Recurrence

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

  6 months

Study Arms (2)

Furosemide

EXPERIMENTAL

Drug: Furosemide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Furosemide DRUG

furosemide

Furosemide

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for functional endoscopic sinus surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Mindy Rabinowitz
• Organization: Thomas Jefferson University

mindy.rabinowitz@jefferson.edu

215-955-6784

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 5, 2017
• Study Start: December 1, 2017
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)