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

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ClinicalTrials.gov Identifier: NCT02403479
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Leigh Sowerby, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Rhinosinusitis Drug: Silver Colloid Other: Saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2 Study Examining the Effects of Topical Intranasal Silver Colloid in Patients With Recalcitrant Chronic Rhinosinusitis
Actual Study Start Date : December 10, 2015
Actual Primary Completion Date : March 6, 2016
Actual Study Completion Date : April 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Saline then Silver Colloid
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
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.
Other Name: Silver Hydrosyl by Sovereign Silver

Other: Saline
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.

Experimental: Silver Colloid then Saline
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
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.
Other Name: Silver Hydrosyl by Sovereign Silver

Other: Saline
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.




Primary Outcome Measures :
  1. Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks. [ Time Frame: 6 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.

  2. Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks [ Time Frame: 6 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403479


Locations
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Canada, Ontario
Saint Joseph's Health Care
London, Ontario, Canada, N6A 4V2
St. Joseph's Health Care
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Leigh Sowerby, MD Schulich School of Medicine and Dentistry/Otolaryngology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leigh Sowerby, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02403479    
Other Study ID Numbers: 106309
First Posted: March 31, 2015    Key Record Dates
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases