Silver Nanoparticle Investigation for Treating Chronic Sinusitis

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

— SNITCH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03243201
• Other study ID #: 159084
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Drug:
• Colloidal silver nanoparticles
Contains 10ppm colloidal silver nanoparticles

Other:
• Purified Water
Purified water will be given as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sino-Nasal Outcome Test (SNOT-22)	Assess change in SNOT-22 score	Four weeks