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Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

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ClinicalTrials.gov Identifier: NCT03362515
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Furosemide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Furosemide Drug: Furosemide
furosemide

Placebo Comparator: Placebo Drug: Placebo
placebo




Primary Outcome Measures :
  1. Polyp Recurrence [ Time Frame: 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 [ Time Frame: 6 months ]
    Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.

  3. Polyp Recurrence [ Time Frame: 6 months ]
    Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362515


Contacts
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Contact: Beth Duddy 215-955-9880 elizabeth.duddy@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Department of Otolaryngology Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Elizabeth Duddy, RN, BSN         
Sponsors and Collaborators
Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03362515     History of Changes
Other Study ID Numbers: 17D.264
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Furosemide
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action