The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis

NCT02403479 | Completed Phase 1 Results

• 1 other identifier: 106309
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when the lining of the sinuses becomes persistently irritated. Standard management options include topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is frequently encountered. Bacterial biofilms are routinely detected within the nasal mucosa of CRSsP patients and are now thought to play an important role in the protracted nature of the disease. Colloidal silver is a widely used naturopathic agent that has recently been shown to eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies. Although silver is currently used in a variety of chronic wound therapies, it has not yet been formally studied in people with CRSsP. It is our intention with this project to determine whether colloidal silver is a useful treatment strategy for patients with refractory CRS.

Conditions

Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

• Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.

  The Sinonasal Outcome Test-22 is a quality of life questionnaire examining the social and emotional distress of CRS. The scores range from 0 to 110 with higher scores representing more severe disease. Total score is reported. Higher values are a worse outcome.

  6 weeks

• Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks

  Endoscopic evaluation of the individual paranasal sinuses (left and right) and the degree of obstruction of the osteomeatal unit. Scores range from 0 to 24 with a higher number representing more severe disease.

  6 weeks

Study Arms (2)

Saline then Silver Colloid

EXPERIMENTAL

Each participant uses 6 weeks of Saline first (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)

Drug: Silver Colloid; Other: Saline

Silver Colloid then Saline

EXPERIMENTAL

Each participant uses 6 weeks of Silver Colloid first (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks).

Drug: Silver Colloid; Other: Saline

Interventions

Silver Colloid DRUG

Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Also known as: Silver Hydrosyl by Sovereign Silver

Saline then Silver Colloid; Silver Colloid then Saline

Saline OTHER

Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays.

Saline then Silver Colloid; Silver Colloid then Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of twelve or more weeks with at least 2 of the following:
• Nasal congestion
• Mucus discharge from the nose or mucus that drips down the back of the throat
• Facial pain or pressure
• A decrease sense of smell
• A history of at least 2 of the following
• One or more failed functional endoscopic sinus surgeries for CRS
• Failed oral, culture-directed antibiotic therapy for CRS
• Failed oral or topical steroid therapy for CRS
• Failed baby shampoo nasal irrigation therapy for CRS
• Failed topical mupirocin therapy for CRS
• Failed Manuka honey irrigations for CRS
• Failed budesonide irrigations for CRS

You may not qualify if:

• Patients with nasal polyposis
• Patients with existing autoimmune disorders
• Patients with an allergy to silver
• Patients with diabetes
• Patients that have previously used colloidal silver as a naturopathic remedy
• Patients that are pregnant, attempting/planning to become pregnant or breastfeeding
• Patients below the age of 18 years

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (2)

Saint Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

St. Joseph's Health Care

London, Ontario, Canada

Location

Related Publications (1)

• Scott JR, Krishnan R, Rotenberg BW, Sowerby LJ. The effectiveness of topical colloidal silver in recalcitrant chronic rhinosinusitis: a randomized crossover control trial. J Otolaryngol Head Neck Surg. 2017 Nov 25;46(1):64. doi: 10.1186/s40463-017-0241-z.

  PMID: 29178954 DERIVED

MeSH Terms

Conditions

Rhinosinusitis

Interventions

colloidal silver; Sodium Chloride

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Leigh Sowerby
• Organization: St. Joseph's Healthcare London

leigh.sowerby@sjhc.london.on.ca

519-646-6143

Study Officials

• Leigh Sowerby, MD

  Schulich School of Medicine and Dentistry/Otolaryngology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 31, 2015
• Study Start: December 10, 2015
• Primary Completion: March 6, 2016
• Study Completion: April 8, 2017
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)