Back to resultsSilver Nanoparticle Investigation for Treating Chronic Sinusitis (SNITCH)
Primary Purpose
Chronic Rhinosinusitis (Diagnosis)
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Colloidal silver nanoparticles
Purified Water
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis)
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Colloidal Silver
Purified Water
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Sino-Nasal Outcome Test (SNOT-22)
Assess change in SNOT-22 score
Secondary Outcome Measures
Full Information
NCT ID
NCT03243201
First Posted
August 4, 2017
Last Updated
May 3, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03243201
Brief Title
Silver Nanoparticle Investigation for Treating Chronic Sinusitis
Acronym
SNITCH
Official Title
The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
IND not approved
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colloidal Silver
Arm Type
Experimental
Arm Description
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.
Arm Title
Purified Water
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Colloidal silver nanoparticles
Other Intervention Name(s)
Sovereign Silver, Bio-Active Silver Hydrosol
Intervention Description
Contains 10ppm colloidal silver nanoparticles
Intervention Type
Other
Intervention Name(s)
Purified Water
Intervention Description
Purified water will be given as placebo
Primary Outcome Measure Information:
Title
Sino-Nasal Outcome Test (SNOT-22)
Description
Assess change in SNOT-22 score
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Silver Nanoparticle Investigation for Treating Chronic Sinusitis
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