Silver Nanoparticle Investigation for Treating Chronic Sinusitis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial

Conditions
-----------------
Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
-----------------
* Drug: Colloidal silver nanoparticles
* Other: Purified Water


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colloidal Silver<br>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. | Drug: Colloidal silver nanoparticles<br>* Contains 10ppm colloidal silver nanoparticles<br>* Other names: Sovereign Silver, Bio-Active Silver Hydrosol;|
| Placebo Comparator: Purified Water<br>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. | Other: Purified Water<br>* Purified water will be given as placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sino-Nasal Outcome Test (SNOT-22) | Assess change in SNOT-22 score | Four weeks |