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Silver Nanoparticle Investigation for Treating Chronic Sinusitis (SNITCH)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03243201
Recruitment Status : Withdrawn (IND not approved)
First Posted : August 8, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE August 4, 2017
First Posted Date  ICMJE August 8, 2017
Last Update Posted Date May 11, 2018
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: Four weeks ]
Assess change in SNOT-22 score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silver Nanoparticle Investigation for Treating Chronic Sinusitis
Official Title  ICMJE The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Rhinosinusitis (Diagnosis)
Intervention  ICMJE
  • Drug: Colloidal silver nanoparticles
    Contains 10ppm colloidal silver nanoparticles
    Other Name: Sovereign Silver, Bio-Active Silver Hydrosol
  • Other: Purified Water
    Purified water will be given as placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Colloidal silver nanoparticles
  • 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.
    Intervention: Other: Purified Water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2017)
40
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03243201
Other Study ID Numbers  ICMJE 159084
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP