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Silver Nanoparticle Investigation for Treating Chronic Sinusitis (SNITCH)

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ClinicalTrials.gov Identifier: NCT03243201
Recruitment Status : Withdrawn (IND not approved)
First Posted : August 8, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

August 4, 2017
August 8, 2017
May 10, 2018
January 2018
December 2018   (Final data collection date for primary outcome measure)
Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: Four weeks ]
Assess change in SNOT-22 score
Same as current
Complete list of historical versions of study NCT03243201 on ClinicalTrials.gov Archive Site
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Silver Nanoparticle Investigation for Treating Chronic Sinusitis
The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Chronic Rhinosinusitis (Diagnosis)
  • 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
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
40
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT03243201
159084
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Not Provided
Washington University School of Medicine
May 2018

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