NCT07383402

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
20mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Chronic Rhinosinusitis (CRS)

Keywords

Povidone IodineBudesonide

Outcome Measures

Primary Outcomes (1)

  • Change in Modified Lund-Kennedy (MLK) Endoscopic Score

    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 Outcomes (1)

  • Scar Tissue Formation

    Up to 24 weeks postoperatively

Study Arms (2)

Povidone-Iodine and Budesonide Gel-Forming Suspension

ACTIVE COMPARATOR

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

Placebo Gel-Forming Suspension

PLACEBO COMPARATOR

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

Interventions

Placebo Gel-Forming SuspensionDRUG

A gel-forming suspension without povidone-iodine or budesonide administered intra-sinus at the completion of endoscopic sinus surgery.

Placebo Gel-Forming Suspension
Povidone-Iodine and Budesonide Gel-Forming SuspensionDRUG

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.

Povidone-Iodine and Budesonide Gel-Forming Suspension

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Amin Javer

CONTACT

604-806-9926sinusdoc@me.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01