<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/NCT02997020</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-160516002</org_study_id>
    <secondary_id>1R01HL133006</secondary_id>
    <nct_id>NCT02997020</nct_id>
  </id_info>
  <brief_title>Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)</brief_title>
  <official_title>Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish the novel endoscopically-directed sinus potential&#xD;
      difference (EDSPD) assay as an endpoint for therapy of sinus disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to establish the novel endoscopically-directed sinus potential&#xD;
      difference (EDSPD) assay as an endpoint for therapy of sinus disease. This assay provides a&#xD;
      means to measure Cl- secretion across the sinus epithelium in human subjects with chronic&#xD;
      rhinosinusitis (CRS) and test the relationship between this data and endoscopic findings of&#xD;
      inflammation. The technique is appropriate for investigating acquired CFTR dysfunction in&#xD;
      sinus epithelium and examining the therapeutic potential of CFTR potentiators for CRS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 18, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ability to measure CFTR difference using EDSPD testing</measure>
    <time_frame>3 Years</time_frame>
    <description>To establish the relationship of EDSPD findings with other validated instruments and markers of CRS disease</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>CRS</condition>
  <arm_group>
    <arm_group_label>CRS Patients</arm_group_label>
    <description>Endoscopically-directed sinus potential difference (EDSPD) will be conducted in either the operating room or in the rhinology clinic setting to quantify CFTR activity in the sinus cavities. The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Patients</arm_group_label>
    <description>Endoscopically-directed sinus potential difference (EDSPD) will be conducted in either the operating room or in the rhinology clinic setting to quantify CFTR activity in the sinus cavities. The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EDSPD</intervention_name>
    <description>The equipment &amp; conditions for measuring bioelectric changes across the sinus mucosa are based on the standard NPD protocol, including use of agar-filled PE90 tubing for the probing electrode and limiting perfusion solutions to Ringer, Ringer + amiloride (100 µM), chloride-free gluconate with amiloride + isoproterenol (10 µM). The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.</description>
    <arm_group_label>CRS Patients</arm_group_label>
    <arm_group_label>Control Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be derived from those patients presenting to UAB for endoscopic&#xD;
        evaluation of CRS, or who present for standard-of-care sinus or skull base surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patient eligibility criteria are designed to limit enrollment otherwise healthy individuals&#xD;
        who are scheduled for standard-of-care nasal endoscopy in the clinic or sinus/skull base&#xD;
        surgery.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
          -  A diagnosis of CRS, as determined by the Sinus and Allergy Health Partnership criteria&#xD;
&#xD;
          -  Has cultured out at least one gram negative bacteria (e.g. Pseudomonas aeruginosa,&#xD;
             Escherichia coli, Stenotrophomonas maltophila) within the previous month&#xD;
&#xD;
          -  Is scheduled for either routine endoscopic surgery or has previously undergone&#xD;
             endoscopic surgery and presents to clinic for routine endoscopic evaluation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Unable to give consent&#xD;
&#xD;
          -  Active diagnosis of cancer, autoimmune disease, or any know immunodeficiency&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brad Woodworth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Brad Woodworth, MD</investigator_full_name>
    <investigator_title>Professor of Otolaryngology</investigator_title>
  </responsible_party>
  <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/NCT02997020
org study id: IRB-160516002
secondary id: 1R01HL133006
nct id: NCT02997020
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to establish the novel endoscopically-directed sinus potential
      difference (EDSPD) assay as an endpoint for therapy of sinus disease.
The purpose of this study is to establish the novel endoscopically-directed sinus potential
      difference (EDSPD) assay as an endpoint for therapy of sinus disease. This assay provides a
      means to measure Cl- secretion across the sinus epithelium in human subjects with chronic
      rhinosinusitis (CRS) and test the relationship between this data and endoscopic findings of
      inflammation. The technique is appropriate for investigating acquired CFTR dysfunction in
      sinus epithelium and examining the therapeutic potential of CFTR potentiators for CRS.
observational model: Case-Control
time perspective: Prospective
measure: Ability to measure CFTR difference using EDSPD testing
time frame: 3 Years
description: To establish the relationship of EDSPD findings with other validated instruments and markers of CRS disease
arm group label: CRS Patients
description: Endoscopically-directed sinus potential difference (EDSPD) will be conducted in either the operating room or in the rhinology clinic setting to quantify CFTR activity in the sinus cavities. The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.
arm group label: Control Patients
description: Endoscopically-directed sinus potential difference (EDSPD) will be conducted in either the operating room or in the rhinology clinic setting to quantify CFTR activity in the sinus cavities. The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.
intervention type: Other
intervention name: EDSPD
description: The equipment & conditions for measuring bioelectric changes across the sinus mucosa are based on the standard NPD protocol, including use of agar-filled PE90 tubing for the probing electrode and limiting perfusion solutions to Ringer, Ringer + amiloride (100 µM), chloride-free gluconate with amiloride + isoproterenol (10 µM). The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.
arm group label: CRS Patients
arm group label: Control Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brad Woodworth, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Brad Woodworth, MD
investigator title: Professor of Otolaryngology
sharing ipd: No