<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/NCT04469439</url>
  </required_header>
  <id_info>
    <org_study_id>20-002079</org_study_id>
    <nct_id>NCT04469439</nct_id>
  </id_info>
  <brief_title>Impact of Sinus Surgery on Individuals With Cystic Fibrosis</brief_title>
  <official_title>The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cystic Fibrosis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</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>
      This study will be a prospective, observational study of patients who undergo endoscopic&#xD;
      sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do&#xD;
      not undergo surgery but are treated medically for CRS will also be enrolled to serve as a&#xD;
      control group. Outcomes analyzed will include pulmonary, quality of life, and others.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pulmonary function</measure>
    <time_frame>baseline, 3, 6, 9, 12 months</time_frame>
    <description>Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in days of inpatient hospitalization</measure>
    <time_frame>baseline, 3, 6, 9, 12 months</time_frame>
    <description>Days of inpatient hospitalization will be assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>baseline, 3, 6, 9, 12 months</time_frame>
    <description>Quality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>baseline, 3, 6, 9, 12 months</time_frame>
    <description>Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in olfaction</measure>
    <time_frame>baseline, 3, 6, 9, 12 months</time_frame>
    <description>Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction regarding treatment for chronic rhinosinusitis</measure>
    <time_frame>at baseline</time_frame>
    <description>Satisfaction will be assessed using 5-point Likert scales, ranging from 1 to 5 with 1 signifying &quot;not important&quot; and 5 signifying &quot;very important&quot;</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Chronic Rhinosinusitis (Diagnosis)</condition>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Surgical group</arm_group_label>
    <description>Individuals with cystic fibrosis and chronic rhinosinusitis who undergo endoscopic sinus surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical group</arm_group_label>
    <description>Individuals with cystic fibrosis and chronic rhinosinusitis who do not undergo endoscopic sinus surgery</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimens are collected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive,&#xD;
             subjects over the age of 89 will be recorded to be 89 years old).&#xD;
&#xD;
          2. Diagnosed with cystic fibrosis as established by genetic testing combined with&#xD;
             clinical assessment and/or sweat chloride&#xD;
&#xD;
          3. Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines&#xD;
&#xD;
          4. chronic rhinosinusitis symptoms persisting beyond initial medical treatment&#xD;
&#xD;
          5. Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient&#xD;
             electing their preferred treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Underwent endoscopic sinus surgery in past 12 months&#xD;
&#xD;
          2. Will obtain follow up care at non-participating institutions&#xD;
&#xD;
          3. Unable to complete follow-up surveys&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel M Beswick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel M Beswick, MD</last_name>
    <phone>310-206-8457</phone>
    <email>dbeswick@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karla Largaespada</last_name>
    <phone>310-794-2514</phone>
    <email>klargaespada@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniel M Beswick, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Daniel M. Beswick</investigator_full_name>
    <investigator_title>Assistant Professor-in-Residence</investigator_title>
  </responsible_party>
  <keyword>Chronic Rhinosinusitis</keyword>
  <keyword>Cystic Fibrosis</keyword>
  <keyword>Endoscopic Sinus Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participant data will securely stored using REDCap software.</ipd_description>
  </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/NCT04469439
org study id: 20-002079
nct id: NCT04469439
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will be a prospective, observational study of patients who undergo endoscopic
      sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do
      not undergo surgery but are treated medically for CRS will also be enrolled to serve as a
      control group. Outcomes analyzed will include pulmonary, quality of life, and others.
observational model: Cohort
time perspective: Prospective
measure: Change in pulmonary function
time frame: baseline, 3, 6, 9, 12 months
description: Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)
measure: Change in days of inpatient hospitalization
time frame: baseline, 3, 6, 9, 12 months
description: Days of inpatient hospitalization will be assessed
measure: Change in quality of life
time frame: baseline, 3, 6, 9, 12 months
description: Quality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life)
measure: Change in quality of life
time frame: baseline, 3, 6, 9, 12 months
description: Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)
measure: Change in olfaction
time frame: baseline, 3, 6, 9, 12 months
description: Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)
measure: Patient satisfaction regarding treatment for chronic rhinosinusitis
time frame: at baseline
description: Satisfaction will be assessed using 5-point Likert scales, ranging from 1 to 5 with 1 signifying "not important" and 5 signifying "very important"
arm group label: Surgical group
description: Individuals with cystic fibrosis and chronic rhinosinusitis who undergo endoscopic sinus surgery
arm group label: Medical group
description: Individuals with cystic fibrosis and chronic rhinosinusitis who do not undergo endoscopic sinus surgery
Specimens are collected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Daniel M Beswick, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Daniel M Beswick, MD
phone: 310-206-8457
email: dbeswick@mednet.ucla.edu
last name: Karla Largaespada
phone: 310-794-2514
email: klargaespada@mednet.ucla.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Daniel M. Beswick
investigator title: Assistant Professor-in-Residence
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No
ipd description: Participant data will securely stored using REDCap software.