<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/NCT03040596</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19040139</org_study_id>
    <nct_id>NCT03040596</nct_id>
  </id_info>
  <brief_title>The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children</brief_title>
  <official_title>The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph Dohar, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Voice disorders are the most common communication disorder across the lifespan and vocal fold&#xD;
      nodules are the most frequent pathology affecting voice in children. The goal of the present&#xD;
      study is to determine the safety and feasibility of a short-course of inhaled corticosteroids&#xD;
      in addition to standard voice therapy for treating vocal fold nodules.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Voice disorders are the most common communication disorder across the lifespan, affecting&#xD;
      more than 5 million school-aged children annually in the United States. Vocal fold nodules&#xD;
      are the most frequent pathology affecting voice in children, with 21% of children negatively&#xD;
      influenced at any given point in time, resulting in negative quality of life consequences and&#xD;
      inferior academic performance. The traditional first-line approach to treatment of vocal fold&#xD;
      nodules is voice therapy by Speech-Language Pathology, although corticosteroids are often&#xD;
      implemented in conjunction with voice therapy to reduce focal inflammation at the lesion&#xD;
      site. Operating room procedures are the traditional method to administer corticosteroids to&#xD;
      the lesion site, although recent advances in office-based laryngeal steroid injections have&#xD;
      become a widely popular alternative to reduce lesion size. Unfortunately, although in-office&#xD;
      injections are more favorable to operating room procedures, due to their less invasive&#xD;
      nature, in-office procedures are still an invasive alternative in the pediatric population.&#xD;
      Specifically, they involve equipment that may be intimidating to the child and require the&#xD;
      child to remain very still for prolonged periods of time, which may not be feasible with some&#xD;
      children. Furthermore, focal vocal fold injections still involve potential adverse effects&#xD;
      such as vocal fold hematoma. To mediate these concerns, a short course of inhaled&#xD;
      corticosteroids may be a safe and non-invasive alternative to reducing inflammation and&#xD;
      lesion size within the larynx. The goal of the present study is to determine the safety and&#xD;
      feasibility of a short-course of inhaled corticosteroids in addition to standard voice&#xD;
      therapy for treating vocal fold nodules. The study also aims to examine the effects of&#xD;
      inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2025</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adverse events</measure>
    <time_frame>1 year after start of voice therapy</time_frame>
    <description>number and type of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>compliance with inhaler use (percent of prescribed doses marked as &quot;taken&quot; on diary)</measure>
    <time_frame>4 weeks</time_frame>
    <description>percent of prescribed doses marked as &quot;taken&quot; on diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fundamental frequency (Hertz)</measure>
    <time_frame>9-12 weeks</time_frame>
    <description>change in fundamental frequency from baseline to end of therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life questionnaire</measure>
    <time_frame>9-12 weeks</time_frame>
    <description>change in score from QOL questionnaire from baseline to end of therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximum phonation time (seconds)</measure>
    <time_frame>9-12 weeks</time_frame>
    <description>change in time from baseline to end of therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>s/z ratio</measure>
    <time_frame>9-12 weeks</time_frame>
    <description>change in ratio of 2 measures from baseline to end of therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Vocal Fold Nodules</condition>
  <arm_group>
    <arm_group_label>inhaled steroid + voice therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>voice therapy only</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>standard voice therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone propionate</intervention_name>
    <description>fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks</description>
    <arm_group_label>inhaled steroid + voice therapy</arm_group_label>
    <other_name>Flovent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard voice therapy</intervention_name>
    <description>Standard voice therapy sessions</description>
    <arm_group_label>inhaled steroid + voice therapy</arm_group_label>
    <arm_group_label>voice therapy only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with vocal fold nodules;&#xD;
&#xD;
          -  Considered behaviorally and cognitively appropriate by PI for voice therapy;&#xD;
&#xD;
          -  English comprehension and production sufficient to participate in the protocol and in&#xD;
             voice therapy;&#xD;
&#xD;
          -  Not currently on inhaled corticosteroids;&#xD;
&#xD;
          -  No previous voice therapy;&#xD;
&#xD;
          -  Willing to participate in voice therapy at Children's Hospital of Pittsburgh&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other medical conditions or medications that would mask or amplify voice outcomes,&#xD;
             including developmental or other neuromuscular conditions, major illness or disorders,&#xD;
             chronic or acute with the exception of laryngopharyngeal reflux disease or allergies&#xD;
             and their treatments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Dohar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ENT Department, Children's Hospital of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amber D Shaffer, PhD</last_name>
    <phone>412-692-6874</phone>
    <email>shafferad@upmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ellen M Mandel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph E Dohar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katherine V Abbot, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Beverly C Richert, PhD, CRNP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katherine White, MA, CCC-SLP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Joseph Dohar, MD</investigator_full_name>
    <investigator_title>Professor of Otolaryngology</investigator_title>
  </responsible_party>
  <keyword>vocal fold nodules</keyword>
  <keyword>inhaled steroid</keyword>
  <keyword>steroid</keyword>
  <keyword>children</keyword>
  <keyword>nodules</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
  </intervention_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/NCT03040596
org study id: STUDY19040139
nct id: NCT03040596
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Voice disorders are the most common communication disorder across the lifespan and vocal fold
      nodules are the most frequent pathology affecting voice in children. The goal of the present
      study is to determine the safety and feasibility of a short-course of inhaled corticosteroids
      in addition to standard voice therapy for treating vocal fold nodules.
Voice disorders are the most common communication disorder across the lifespan, affecting
      more than 5 million school-aged children annually in the United States. Vocal fold nodules
      are the most frequent pathology affecting voice in children, with 21% of children negatively
      influenced at any given point in time, resulting in negative quality of life consequences and
      inferior academic performance. The traditional first-line approach to treatment of vocal fold
      nodules is voice therapy by Speech-Language Pathology, although corticosteroids are often
      implemented in conjunction with voice therapy to reduce focal inflammation at the lesion
      site. Operating room procedures are the traditional method to administer corticosteroids to
      the lesion site, although recent advances in office-based laryngeal steroid injections have
      become a widely popular alternative to reduce lesion size. Unfortunately, although in-office
      injections are more favorable to operating room procedures, due to their less invasive
      nature, in-office procedures are still an invasive alternative in the pediatric population.
      Specifically, they involve equipment that may be intimidating to the child and require the
      child to remain very still for prolonged periods of time, which may not be feasible with some
      children. Furthermore, focal vocal fold injections still involve potential adverse effects
      such as vocal fold hematoma. To mediate these concerns, a short course of inhaled
      corticosteroids may be a safe and non-invasive alternative to reducing inflammation and
      lesion size within the larynx. The goal of the present study is to determine the safety and
      feasibility of a short-course of inhaled corticosteroids in addition to standard voice
      therapy for treating vocal fold nodules. The study also aims to examine the effects of
      inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: adverse events
time frame: 1 year after start of voice therapy
description: number and type of adverse events
measure: compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
time frame: 4 weeks
description: percent of prescribed doses marked as "taken" on diary
measure: fundamental frequency (Hertz)
time frame: 9-12 weeks
description: change in fundamental frequency from baseline to end of therapy
measure: quality of life questionnaire
time frame: 9-12 weeks
description: change in score from QOL questionnaire from baseline to end of therapy
measure: maximum phonation time (seconds)
time frame: 9-12 weeks
description: change in time from baseline to end of therapy
measure: s/z ratio
time frame: 9-12 weeks
description: change in ratio of 2 measures from baseline to end of therapy
arm group label: inhaled steroid + voice therapy
arm group type: Experimental
description: fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy
arm group label: voice therapy only
arm group type: Other
description: standard voice therapy
intervention type: Drug
intervention name: Fluticasone propionate
description: fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks
arm group label: inhaled steroid + voice therapy
other name: Flovent
intervention type: Behavioral
intervention name: Standard voice therapy
description: Standard voice therapy sessions
arm group label: inhaled steroid + voice therapy
arm group label: voice therapy only
criteria: 
gender: All
minimum age: 4 Years
maximum age: 11 Years
healthy volunteers: No
last name: Joseph Dohar, MD
role: Principal Investigator
affiliation: ENT Department, Children's Hospital of Pittsburgh
last name: Amber D Shaffer, PhD
phone: 412-692-6874
email: shafferad@upmc.edu
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Joseph Dohar, MD
investigator title: Professor of Otolaryngology
mesh term: Respiratory Aspiration
mesh term: Fluticasone
mesh term: Xhance
sharing ipd: No