The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial
| Registry | NCT03243201, acronym SNITCH |
|---|---|
| Status | Withdrawn - IND not approved |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Sponsor | Washington University School of Medicine (Other) |
| Conditions | Chronic Rhinosinusitis (Diagnosis) |
| Interventions | Colloidal silver nanoparticles, Purified Water (Drug, other) |
| Dates | start 2018-01-01 (estimated), primary completion 2018-12-01 (estimated), completion 2018-12-01 (estimated), first posted 2017-08-08, last updated 2018-05-11 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Colloidal Silver | Experimental | Drug: Colloidal silver nanoparticles | The colloidal silver arm will administer intranasal colloidal silver, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day (8 mcg of silver per day), for 28 days. |
| Purified Water | Placebo comparator | Other: Purified Water | The placebo arm will administer intranasal purified water, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day, for 28 days. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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