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

Amin Javer

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Chronic Rhinosinusitis (CRS)

Treatments: Drug: Povidone-Iodine and Budesonide Gel-Forming Suspension; Drug: Placebo Gel-Forming Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT07383402

H24-02473

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Povidone-Iodine and Budesonide Gel-Forming Suspension

Active Comparator group

Description:

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.

Treatment:

Drug: Povidone-Iodine and Budesonide Gel-Forming Suspension

Placebo Gel-Forming Suspension

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Gel-Forming Suspension