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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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