<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/NCT04421092</url>
  </required_header>
  <id_info>
    <org_study_id>00096384</org_study_id>
    <nct_id>NCT04421092</nct_id>
  </id_info>
  <brief_title>Efficacy of SLN Block for Chronic Cough</brief_title>
  <official_title>Efficacy of Superior Laryngeal Nerve Block for Chronic Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <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>
      This is a research study to find out if superior laryngeal nerve blocks are an effective way&#xD;
      to reduce cough when compared to placebo (a substance without any medical value). Eligibility&#xD;
      for the study include the following: age &gt;18, cough history suggestive that the nerve to the&#xD;
      voice box is overactive, non-smoker, Patients will be followed over time and assigned to&#xD;
      either the treatment or placebo group at random. The treatment would be four superior&#xD;
      laryngeal nerve blocks and the placebo would be four saline injections (the inactive&#xD;
      substance). Study team will measure if the injection improved cough and ask patients to keep&#xD;
      a log of symptoms and fill out questionnaires at each visit. After the four injections,&#xD;
      patients will follow up in 3 months to see if cough has returned and if so, how severe the&#xD;
      cough is.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <phase>Phase 2</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cough severity</measure>
    <time_frame>Baseline, every two weeks (+/- 1 week) post-treatment (estimated 3 months total)</time_frame>
    <description>Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective improvement in cough</measure>
    <time_frame>Every two weeks (+/- 1 week) post-treatment (estimated 3 months total), 3 months post completion of therapy</time_frame>
    <description>Patient will state dichotomously &quot;yes&quot; or &quot;no&quot; if cough overall improved at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily change in subjective cough severity</measure>
    <time_frame>Daily after each treatment (estimated 3 months total)</time_frame>
    <description>Patient will fill out a Visual Analogue Scale measuring cough severity. Patients will be given a log to complete daily after treatment completed and instructed to mark on a line with a &quot;X&quot; how severe the cough is. The far left of the line will indicate no cough at all, and the far right is indicative of the most severe cough.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cough</condition>
  <condition>Superior Laryngeal Nerve Block</condition>
  <condition>Neurogenic Cough</condition>
  <arm_group>
    <arm_group_label>Steroid-Lidocaine Mixture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive numbing injection, which is a mixture of steroid and lidocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Will receive saline injection as a placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Superior laryngeal nerve block</intervention_name>
    <description>Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Steroid-Lidocaine Mixture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Injection of placebo (saline)</intervention_name>
    <description>Superior laryngeal nerve block using 1mL of saline as the injection.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Injection of steroid-lidocaine mixture</intervention_name>
    <description>Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.</description>
    <arm_group_label>Steroid-Lidocaine Mixture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History consistent with neurogenic cough&#xD;
&#xD;
          -  Exclusion of other etiologies (see exclusion criteria)&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current neuromodulating medication use&#xD;
&#xD;
          -  Untreated other etiologies of cough:&#xD;
&#xD;
        Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal&#xD;
        CXR within 6 months RSI &gt; 13 or RFS &gt;11 AND workup positive for GERD (esophagram, 24-hour&#xD;
        pH probe, manometry, EGD)&#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>
  <overall_official>
    <last_name>Courtney Tipton</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Courtney Tipton</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>superior laryngeal nerve block</keyword>
  <keyword>chronic cough</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cough</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT04421092
org study id: 00096384
nct id: NCT04421092
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a research study to find out if superior laryngeal nerve blocks are an effective way
      to reduce cough when compared to placebo (a substance without any medical value). Eligibility
      for the study include the following: age >18, cough history suggestive that the nerve to the
      voice box is overactive, non-smoker, Patients will be followed over time and assigned to
      either the treatment or placebo group at random. The treatment would be four superior
      laryngeal nerve blocks and the placebo would be four saline injections (the inactive
      substance). Study team will measure if the injection improved cough and ask patients to keep
      a log of symptoms and fill out questionnaires at each visit. After the four injections,
      patients will follow up in 3 months to see if cough has returned and if so, how severe the
      cough is.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in cough severity
time frame: Baseline, every two weeks (+/- 1 week) post-treatment (estimated 3 months total)
description: Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.
measure: Subjective improvement in cough
time frame: Every two weeks (+/- 1 week) post-treatment (estimated 3 months total), 3 months post completion of therapy
description: Patient will state dichotomously "yes" or "no" if cough overall improved at each visit.
measure: Daily change in subjective cough severity
time frame: Daily after each treatment (estimated 3 months total)
description: Patient will fill out a Visual Analogue Scale measuring cough severity. Patients will be given a log to complete daily after treatment completed and instructed to mark on a line with a "X" how severe the cough is. The far left of the line will indicate no cough at all, and the far right is indicative of the most severe cough.
arm group label: Steroid-Lidocaine Mixture
arm group type: Experimental
description: Will receive numbing injection, which is a mixture of steroid and lidocaine
arm group label: Placebo
arm group type: Placebo Comparator
description: Will receive saline injection as a placebo
intervention type: Procedure
intervention name: Superior laryngeal nerve block
description: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.
arm group label: Placebo
arm group label: Steroid-Lidocaine Mixture
intervention type: Procedure
intervention name: Injection of placebo (saline)
description: Superior laryngeal nerve block using 1mL of saline as the injection.
arm group label: Placebo
intervention type: Procedure
intervention name: Injection of steroid-lidocaine mixture
description: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.
arm group label: Steroid-Lidocaine Mixture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Courtney Tipton
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Courtney Tipton
investigator title: Principal Investigator
mesh term: Cough
mesh term: Lidocaine
sharing ipd: No