Trial Outcomes & Findings for The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis (NCT NCT02403479)
NCT ID: NCT02403479
Last Updated: 2019-11-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
Saline, Then Silver Colloid
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
|
Silver Colloid, Then 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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Saline Then Silver Colloid
n=10 Participants
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)
|
Silver Colloid Then Saline
n=12 Participants
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
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=10 Participants
|
8 Participants
n=12 Participants
|
15 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=22 Participants
|
|
Age, Continuous
|
65.8 years
n=10 Participants
|
62.3 years
n=12 Participants
|
64.7 years
n=22 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
8 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
10 Participants
n=12 Participants
|
14 Participants
n=22 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
10 Participants
n=10 Participants
|
12 Participants
n=12 Participants
|
22 Participants
n=22 Participants
|
|
SNOT-22 score
|
59.3 units on a scale
STANDARD_DEVIATION 19.4 • n=10 Participants
|
52.8 units on a scale
STANDARD_DEVIATION 19.2 • n=12 Participants
|
54.2 units on a scale
STANDARD_DEVIATION 20.1 • n=22 Participants
|
|
Lund-Kennedy endoscopic score
|
7.8 units on a scale
STANDARD_DEVIATION 2.2 • n=10 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 2.3 • n=12 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 2.2 • n=22 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
Saline, Then Silver Colloid
n=8 Participants
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.
|
Silver Colloid, Then Saline
n=12 Participants
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.
|
|---|---|---|
|
Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.
baseline
|
59.3 units on a scale
Standard Deviation 19.4
|
52.9 units on a scale
Standard Deviation 19.2
|
|
Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.
6 weeks
|
45.4 units on a scale
Standard Deviation 16.8
|
51.8 units on a scale
Standard Deviation 24.4
|
|
Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.
12 weeks
|
49.3 units on a scale
Standard Deviation 17.9
|
56.5 units on a scale
Standard Deviation 23.5
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: chronic rhinosinusitis without polyposis patients
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.
Outcome measures
| Measure |
Saline, Then Silver Colloid
n=8 Participants
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.
|
Silver Colloid, Then Saline
n=12 Participants
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.
|
|---|---|---|
|
Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks
12 weeks
|
4.8 score on a scale
Standard Deviation 2.7
|
4.7 score on a scale
Standard Deviation 1.6
|
|
Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks
baseline
|
7.8 score on a scale
Standard Deviation 2.2
|
6.8 score on a scale
Standard Deviation 2.3
|
|
Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks
6 weeks
|
5.9 score on a scale
Standard Deviation 1.6
|
5.7 score on a scale
Standard Deviation 2.8
|
Adverse Events
Saline Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colloidal Silver Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saline Intervention
n=22 participants at risk
Adverse events that occurred during time using saline intervention are reported here.
|
Colloidal Silver Intervention
n=22 participants at risk
Adverse events that occurred during time using colloidal silver intervention are reported here.
|
|---|---|---|
|
Infections and infestations
Acute exacerbation of sinusitis/severe nasal obstruction
|
0.00%
0/22 • Adverse events were collected over the entire 12 week period patients were enrolled in the study.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected over the entire 12 week period patients were enrolled in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place