Intra-Sinus Povidone-Iodine and Budesonide After Endoscopic Sinus Surgery for Chronic Rhinosinusitis (PVP-I)

January 26, 2026 updated by: Amin Javer

The Efficacy of Intra-sinus Povidone-iodine/Budesonide Gel Forming Suspension Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: a Randomized, Double Blind, Placebo-controlled Trial

Endoscopic sinus surgery (ESS) is commonly performed in patients with chronic rhinosinusitis (CRS) to improve sinus drainage and allow better delivery of topical therapies after surgery. Despite surgery, postoperative inflammation can persist and negatively affect healing and outcomes.

This randomized, double-blind, placebo-controlled clinical trial will evaluate whether intra-sinus administration of a gel-forming suspension containing povidone-iodine and budesonide improves postoperative endoscopic outcomes of the sinus cavities three months following ESS, compared with placebo.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic rhinosinusitis (CRS) is a chronic inflammatory condition that can significantly impact quality of life. Endoscopic sinus surgery (ESS) is performed in patients with CRS who do not respond adequately to medical therapy, with the goals of improving sinus drainage, reducing disease burden, and facilitating postoperative topical treatment delivery. However, postoperative inflammation and impaired mucosal healing may persist despite surgery and standard postoperative care.

Povidone-iodine (PVP-I) has broad antimicrobial and anti-inflammatory properties, while budesonide is a corticosteroid commonly used intranasally to reduce sinonasal inflammation. Although both agents are individually used in sinonasal care, the efficacy and safety of their combined intra-sinus administration in a gel-forming suspension following ESS have not been well established.

This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of an intra-sinus gel-forming suspension containing PVP-I and budesonide administered at the time of ESS in adult patients with CRS. Participants will be randomized to receive either the investigational gel-forming suspension or a placebo gel following completion of surgery.

Participants will be followed postoperatively according to standard clinical care. The primary outcome will assess endoscopic appearance of the sinus cavities three months following ESS using a validated endoscopic scoring system. Secondary outcomes will evaluate postoperative sinonasal symptoms, mucosal healing, and treatment-related adverse events.

The results of this study will help determine whether intra-sinus delivery of a combined PVP-I and budesonide gel-forming suspension improves postoperative endoscopic outcomes and supports its use as an adjunctive therapy following ESS in patients with CRS.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age 19 years or older Scheduled for Endoscopic Sinus Surgery (ESS)

Exclusion Criteria:

Cystic fibrosis Systemic vasculitis Known or suspected hypersensitivity to povidone iodine Inhaled drug use (i.e., cocaine) in the preceding 6 months Nasal tumors Known or suspected immunodeficiencies Pregnant women Breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Povidone-Iodine and Budesonide Gel-Forming Suspension
Participants randomized to this arm will receive an intra-sinus gel-forming suspension containing povidone-iodine and budesonide administered at the completion of endoscopic sinus surgery.
Drug: Povidone-Iodine and Budesonide Gel-Forming Suspension
A gel-forming suspension containing povidone-iodine and budesonide administered intra-sinus at the completion of endoscopic sinus surgery, intended to reduce postoperative inflammation and improve sinus cavity healing.
Placebo Comparator: Placebo Gel-Forming Suspension
Participants randomized to this arm will receive an intra-sinus placebo gel-forming suspension without active drug administered at the completion of endoscopic sinus surgery.
Drug: Placebo Gel-Forming Suspension
A gel-forming suspension without povidone-iodine or budesonide administered intra-sinus at the completion of endoscopic sinus surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Lund-Kennedy (MLK) Endoscopic Score
Time Frame: 12 weeks postoperatively
Change in the Modified Lund-Kennedy (MLK) endoscopic score comparing baseline to 12 weeks following endoscopic sinus surgery. The MLK score is a validated endoscopic scoring system assessing sinonasal inflammation, including edema and polyps, with higher scores indicating worse disease severity.
12 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Tissue Formation
Time Frame: Up to 24 weeks postoperatively
Presence and severity of postoperative scar tissue formation assessed by nasal endoscopy.
Up to 24 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amin Javer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-02473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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