Silver Nanoparticle Investigation for Treating Chronic Sinusitis

NCT03243201 | Withdrawn Phase 1

• 1 other identifier: 159084
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Sino-Nasal Outcome Test (SNOT-22)

  Assess change in SNOT-22 score

  Four weeks

Study Arms (2)

Colloidal Silver

EXPERIMENTAL

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

Purified Water

PLACEBO COMPARATOR

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

Interventions

Colloidal silver nanoparticles DRUG

Contains 10ppm colloidal silver nanoparticles

Also known as: Sovereign Silver, Bio-Active Silver Hydrosol

Colloidal Silver

Purified Water OTHER

Purified water will be given as placebo

Purified Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share