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Silver Nanoparticle Investigation for Treating Chronic Sinusitis (SNITCH)

This study is not yet open for participant recruitment.
Verified August 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03243201
First Posted: August 8, 2017
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Colloidal silver nanoparticles Other: Purified Water Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: Four weeks ]
    Assess change in SNOT-22 score


Estimated Enrollment: 40
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colloidal Silver
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.
Drug: Colloidal silver nanoparticles
Contains 10ppm colloidal silver nanoparticles
Other Name: Sovereign Silver, Bio-Active Silver Hydrosol
Placebo Comparator: Purified Water
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.
Other: Purified Water
Purified water will be given as placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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): NCT03243201


Contacts
Contact: Christina G Kwong, MD 314-286-2780 kwongc@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03243201     History of Changes
Other Study ID Numbers: 159084
First Submitted: August 4, 2017
First Posted: August 8, 2017
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes