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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Rhinosinusitis
Interventions Drug: Silver Colloid
Other: Saline
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline, Then Silver Colloid Silver Colloid, Then Saline
Hide Arm/Group Description

Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)

Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril twice daily for a total of 6 weeks. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Topical Saline

Cross-over control Each participant receives 6 weeks of topical nasal silver colloid, followed by 6 weeks of saline (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)

Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril twice daily for a total of 6 weeks. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Period Title: Overall Study
Started 10 12
Completed 8 12
Not Completed 2 0
Arm/Group Title Saline Then Silver Colloid Silver Colloid Then Saline Total
Hide Arm/Group Description Each participant uses 6 weeks of saline (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) Each participant uses 6 weeks of silver colloid (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). Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  70.0%
8
  66.7%
15
  68.2%
>=65 years
3
  30.0%
4
  33.3%
7
  31.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 22 participants
65.8
(44 to 86)
62.3
(43 to 84)
64.7
(43 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
6
  60.0%
2
  16.7%
8
  36.4%
Male
4
  40.0%
10
  83.3%
14
  63.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 10 participants 12 participants 22 participants
10
 100.0%
12
 100.0%
22
 100.0%
SNOT-22 score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 12 participants 22 participants
59.3  (19.4) 52.8  (19.2) 54.2  (20.1)
[1]
Measure Description: The SNOT-22 questionnaire is a 22-item document that assesses the social and emotional impact of CRS. Scores may range from 0-110 with higher scores representing more severe disease
Lund-Kennedy endoscopic score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 12 participants 22 participants
7.8  (2.2) 6.8  (2.3) 7.1  (2.2)
[1]
Measure Description: The Lund Kennedy endoscopic score is an objective measure of the severity of CRS. Scores are given to reflect the degree of edema and obstruction within the various sinuses. Scores range from 0 to 12 with higher scores being worse.
1.Primary Outcome
Title Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline, Then Silver Colloid Silver Colloid, Then Saline
Hide Arm/Group Description:

Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)

Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Each participant receives the full 12 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)

Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Overall Number of Participants Analyzed 8 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 59.3  (19.4) 52.9  (19.2)
6 weeks 45.4  (16.8) 51.8  (24.4)
12 weeks 49.3  (17.9) 56.5  (23.5)
2.Primary Outcome
Title Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
chronic rhinosinusitis without polyposis patients
Arm/Group Title Saline Then Silver Colloid Silver Colloid Then Saline
Hide Arm/Group Description:

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)

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.

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.

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).

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.

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.

Overall Number of Participants Analyzed 8 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 7.8  (2.2) 6.8  (2.3)
6 weeks 5.9  (1.6) 5.7  (2.8)
12 weeks 4.8  (2.7) 4.7  (1.6)
Time Frame Adverse events were collected over the entire 12 week period patients were enrolled in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Intervention Colloidal Silver Intervention
Hide Arm/Group Description Adverse events that occurred during time using saline intervention are reported here. Adverse events that occurred during time using colloidal silver intervention are reported here.
All-Cause Mortality
Saline Intervention Colloidal Silver Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Saline Intervention Colloidal Silver Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Intervention Colloidal Silver Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      2/22 (9.09%)    
Infections and infestations     
Acute exacerbation of sinusitis/severe nasal obstruction   0/22 (0.00%)  0 2/22 (9.09%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Leigh Sowerby
Organization: St. Joseph's Healthcare London
Phone: 519-646-6143
EMail: leigh.sowerby@sjhc.london.on.ca
Layout table for additonal information
Responsible Party: Leigh Sowerby, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02403479    
Other Study ID Numbers: 106309
First Submitted: March 1, 2015
First Posted: March 31, 2015
Results First Submitted: April 11, 2017
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019