Silver Nanoparticle Investigation for Treating Chronic Sinusitis

Washington University School of Medicine

Overview

Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden. Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely contributor to recalcitrant disease. Emerging evidence shows that colloidal silver nanoparticles may be effective for reducing biofilms. The investigators intend to perform a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness and safety of intranasal colloidal silver nanoparticles in adult patients with chronic rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement in symptom scores and will not be associated with increased rate of adverse effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Chronic Rhinosinusitis (Diagnosis)

Interventions

Colloidal silver nanoparticlesDRUG

Contains 10ppm colloidal silver nanoparticles

Purified WaterOTHER

Purified water will be given as placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS): * mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion), facial pain-pressure-fullness, or decreased sense of smell AND inflammation is documented by one or more of the following findings: * purulent (not clear) mucus or edema in the middle meatus or ethmoid region * polyps in nasal cavity or the middle meatus * and/or radiographic imaging showing inflammation of the paranasal sinuses Exclusion Criteria: * Unable to speak English * History of nasal or sinus surgery within past 6 weeks * History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition * Dependence on prolonged corticosteroid therapy for comorbid condition * History of renal impairment * History of cerebrospinal fluid leak

Outcomes

Primary Outcomes

Sino-Nasal Outcome Test (SNOT-22)

Assess change in SNOT-22 score

Time frame: Four weeks

Data from ClinicalTrials.gov

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