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Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

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Thomas Jefferson University

Status and phase

Terminated
Phase 2

Conditions

Nasal Polyps

Treatments

Drug: Placebo
Drug: Furosemide

Study type

Interventional

Funder types

Other

Identifiers

NCT03362515
17D.264

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

18 participants in 2 patient groups, including a placebo group

Furosemide
Experimental group
Treatment:
Drug: Furosemide
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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