<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243201</url>
  </required_header>
  <id_info>
    <org_study_id>159084</org_study_id>
    <nct_id>NCT03243201</nct_id>
  </id_info>
  <brief_title>Silver Nanoparticle Investigation for Treating Chronic Sinusitis</brief_title>
  <acronym>SNITCH</acronym>
  <official_title>The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden.&#xD;
      Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely&#xD;
      contributor to recalcitrant disease. Emerging evidence shows that colloidal silver&#xD;
      nanoparticles may be effective for reducing biofilms. The investigators intend to perform a&#xD;
      randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness&#xD;
      and safety of intranasal colloidal silver nanoparticles in adult patients with chronic&#xD;
      rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with&#xD;
      intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement&#xD;
      in symptom scores and will not be associated with increased rate of adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IND not approved&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sino-Nasal Outcome Test (SNOT-22)</measure>
    <time_frame>Four weeks</time_frame>
    <description>Assess change in SNOT-22 score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Rhinosinusitis (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>Colloidal Silver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Purified Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colloidal silver nanoparticles</intervention_name>
    <description>Contains 10ppm colloidal silver nanoparticles</description>
    <arm_group_label>Colloidal Silver</arm_group_label>
    <other_name>Sovereign Silver, Bio-Active Silver Hydrosol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Purified Water</intervention_name>
    <description>Purified water will be given as placebo</description>
    <arm_group_label>Purified Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Twelve (12) weeks or longer of two or more of the following signs and symptom consistent&#xD;
        with chronic rhinosinusitis (CRS):&#xD;
&#xD;
          -  mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),&#xD;
             facial pain-pressure-fullness, or decreased sense of smell&#xD;
&#xD;
        AND inflammation is documented by one or more of the following findings:&#xD;
&#xD;
          -  purulent (not clear) mucus or edema in the middle meatus or ethmoid region&#xD;
&#xD;
          -  polyps in nasal cavity or the middle meatus&#xD;
&#xD;
          -  and/or radiographic imaging showing inflammation of the paranasal sinuses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak English&#xD;
&#xD;
          -  History of nasal or sinus surgery within past 6 weeks&#xD;
&#xD;
          -  History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary&#xD;
             condition&#xD;
&#xD;
          -  Dependence on prolonged corticosteroid therapy for comorbid condition&#xD;
&#xD;
          -  History of renal impairment&#xD;
&#xD;
          -  History of cerebrospinal fluid leak&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243201
org study id: 159084
nct id: NCT03243201
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Sino-Nasal Outcome Test (SNOT-22)
time frame: Four weeks
description: Assess change in SNOT-22 score
arm group label: Colloidal Silver
arm group type: Experimental
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 group label: Purified Water
arm group type: Placebo Comparator
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: Colloidal silver nanoparticles
description: Contains 10ppm colloidal silver nanoparticles
arm group label: Colloidal Silver
other name: Sovereign Silver, Bio-Active Silver Hydrosol
intervention type: Other
intervention name: Purified Water
description: Purified water will be given as placebo
arm group label: Purified Water
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Chronic Disease
sharing ipd: No