<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/NCT04468542</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY001182</org_study_id>
    <nct_id>NCT04468542</nct_id>
  </id_info>
  <brief_title>Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough</brief_title>
  <official_title>Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Florida</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective randomized placebo-controlled trial assessing the efficacy of superior laryngeal&#xD;
      nerve block for adults with neurogenic cough refractory to proton pump inhibitor as&#xD;
      determined by improvement in validated cough severity questionnaires before and after&#xD;
      injection of Marcaine and Kenalog compared to placebo (saline injection).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abbreviations/ Definitions: cough severity index (CSI), Cough quality of life questionnaire&#xD;
      (CQLQ), proton pump inhibitor (PPI), nasopharyngolaryngoscopy (NPL), University of South&#xD;
      Florida (USF), superior laryngeal nerve (SLN), upper airway cough syndrome (UACS), food and&#xD;
      drug administration (FDA), investigational new drug (IND), medical record number (MRN),&#xD;
      electronic medical record (EMR), ear nose and throat (ENT), angiotensin converting enzyme&#xD;
      (ACE), chronic rhinosinusitis (CRS), gastroesophageal reflux disorder (GERD), pulmonary&#xD;
      function test (PFT), Reflux finding score (RFS), Speech and language pathology (SLP)&#xD;
&#xD;
      Participants will be referred into (via other USF affiliated departments) or recruited within&#xD;
      the University of South Florida Department of Otolaryngology practice. Individuals will be&#xD;
      screened for eligibility based on referral description. Eligibility will be determined by&#xD;
      history at initial visit based on inclusion and exclusion criteria. Eligible participants&#xD;
      will be adults with chronic cough &gt;8 weeks duration and presumed neurogenic cough based on&#xD;
      initial evaluation. Chronic throat clearing with foreign body sensation for &gt;8 weeks duration&#xD;
      will also meet criteria for inclusion and will be used synonymously with and considered&#xD;
      chronic cough for the remainder of this protocol and study. Patients will be excluded if&#xD;
      primary cause is determined to not be neurogenic. Patients will be excluded if there are&#xD;
      other possible significant contributors to the cough that have not been treated (no other&#xD;
      obvious treatable and untreated cause), or they will be treated per the standard of care&#xD;
      prior to enrolling in this study. Patients will be screened for at least a 4-week course of&#xD;
      PPI therapy during duration of symptoms. Patients with possible UACS were included if a trial&#xD;
      of medications had been completed previously. If patients are on long term medications that&#xD;
      are effective for their respective related condition (but still ineffective at adequately&#xD;
      controlling chronic cough), they will be encouraged to make no unnecessary changes through&#xD;
      treatment/study duration. These include acid suppression therapy (outside of the recent&#xD;
      6-week trial of PPI if applicable), therapy for UACS symptoms if indicated (eg, Flonase and&#xD;
      antihistamine, saline rinses, etc.), neuromodulators (e.g., gabapentin). Patients were&#xD;
      excluded if they started any of these medications in last month and were not willing to&#xD;
      discontinue them for the duration of the trial. Participants must be willing and able to&#xD;
      consent to participate in the study, be willing to be assigned to and undergo intervention or&#xD;
      the placebo, and be willing to adhere to the study protocol for the duration of the trial:&#xD;
      2-4 visits, approximately 3 weeks of treatment, 6 week PPI trial with 4 week discontinuation&#xD;
      period if no improvement (if applicable), up to 12 week follow up questionnaires (survey&#xD;
      only), participate in cough suppression, take PPI as prescribed for duration specified.&#xD;
&#xD;
      Participants were excluded if at any point they met the following criteria: unwilling to&#xD;
      participate in protocol, allergic to Bupivacaine or triamcinolone acetonide suspension,&#xD;
      presence of severe uncontrolled medical condition, any significant pulmonary processes&#xD;
      (including chronic obstructive pulmonary disease, bronchiectasis, non-asthmatic eosinophilic&#xD;
      bronchitis, structural abnormalities, etc.), presence of asthma (determined by presence of&#xD;
      abnormal pulmonary function test (PFT) provocation testing), concern for aerodigestive tract&#xD;
      malignancy from history or exam, structural abnormality seen on NPL or prior imaging,&#xD;
      immunocompromised, current smoker, use of ACE inhibitor at time of or one month preceding&#xD;
      first injection, or vulnerable population.&#xD;
&#xD;
      Eligible participants underwent NPL will be also conducted at initial visit (Reflux finding&#xD;
      score, RFS). Informed consent will be obtained at this time. Demographics (including sex,&#xD;
      age, past medical history, related comorbidities, sidedness of globus sensation,&#xD;
      neuromodulator use, results of any prior chest radiograph during symptom duration, ever&#xD;
      referred to SLP for voice therapy) will be recorded at initial visit. Related comorbidities&#xD;
      include UACS, allergic rhinitis, CRS, GERD. Patients who had not previously received adequate&#xD;
      PPI trial were placed in 4 to 6-week course and encourage/counseled to complete lifestyle&#xD;
      modifications to reduce reflux. Patients with less than complete response to PPI (persistent&#xD;
      clinically significant cough) therapy were included in study. Patients follow-up visit for&#xD;
      consideration of injection was schedule one month after discontinuing PPI trial.&#xD;
      Questionnaire scores were determined immediately prior to first injection. All patients were&#xD;
      counseled on cough suppression prior to initial injection. Patients were randomly assigned to&#xD;
      placebo (2-cc normal saline) or intervention (total of 2-cc injection, mixture consisting of&#xD;
      1-cc of Bupivacaine and 1-cc of Kenolog-40) injection groups using computer-generated random&#xD;
      assignment. Injections will begin at initial visit or at follow-up visit if trial of PPI&#xD;
      required. Immediately preceding injections, patients will be given 5 sprays of 4% topical&#xD;
      lidocaine to facilitate injection which will also act to facilitate patient blinding.&#xD;
      Injection will be delivered into the region of the proximal superior laryngeal nerve using&#xD;
      greater cornu of hyoid and superior cornu of thyroid cartilage as landmarks. Injection will&#xD;
      be placed 1-cm anterior to the midpoint of these landmarks.&#xD;
&#xD;
      If globus sensation or trigger site was localized to one side, this was recorded and initial&#xD;
      injection was directed at this side, otherwise this was picked at random. The second&#xD;
      injection was directed at the same side if partial improvement (patient's subjective sense of&#xD;
      least 50% reduction of symptoms) was observed after the first injection. The second injection&#xD;
      was directed at the contralateral side if there was no initial improvement. Third injection&#xD;
      was offered if there was improvement during either of the first two injections (completed on&#xD;
      the ipsilateral side of prior two injections or the side with most improvement if bilateral&#xD;
      had been completed). There was no second/third injection if complete resolution of symptoms&#xD;
      was observed after the preceding injection. Follow up for repeat injection will be scheduled&#xD;
      in 1-2 weeks, and exact time recorded. Questionnaire scores were then recorded 2 weeks after&#xD;
      final injection of the series. Surveys (see next section, CSI and CQLQ) will also be sent for&#xD;
      patients to complete at 6 and 12 weeks after last injection, which will be analyzed in&#xD;
      subsequent study. Surveys will have a one-week window to be considered in their nominal&#xD;
      category. All adverse events will be recorded. See data capture sheet for collected&#xD;
      variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 3</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>2 week post-treatment cough severity index score improvement</measure>
    <time_frame>Immediately pre-treatment and post-treatment at 2 weeks</time_frame>
    <description>Measure of efficacy of intervention by comparing change in pre-treatment and 2 week post-treatment cough severity index scores between intervention to placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2 week post-treatment cough-specific quality-of-life questionnaire score improvement</measure>
    <time_frame>Immediately pre-treatment and post-treatment at 2 weeks</time_frame>
    <description>Measure of efficacy of intervention by comparing change in pre-treatment and 2 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6 week post-treatment cough severity index score improvement</measure>
    <time_frame>Immediately pre-treatment and post-treatment at 6 weeks</time_frame>
    <description>Measure of efficacy of intervention by comparing change in pre-treatment and 6 week post-treatment cough severity index scores between intervention to placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 week post-treatment cough severity index score improvement</measure>
    <time_frame>Immediately pre-treatment and post-treatment at 12 weeks</time_frame>
    <description>Measure of efficacy of intervention by comparing change in pre-treatment and 12 week post-treatment cough severity index scores between intervention to placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 week post-treatment cough-specific quality-of-life questionnaire score improvement</measure>
    <time_frame>Immediately pre-treatment and post-treatment at 6 weeks</time_frame>
    <description>Measure of efficacy of intervention by comparing change in pre-treatment and 6 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 week post-treatment cough-specific quality-of-life questionnaire score improvement</measure>
    <time_frame>Immediately pre-treatment and post-treatment at 12 weeks</time_frame>
    <description>Measure of efficacy of intervention by comparing change in pre-treatment and 12 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Cough</condition>
  <condition>Nerve Block</condition>
  <arm_group>
    <arm_group_label>Bupivacaine/triamcinolone injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2-cc injection of normal saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)</intervention_name>
    <description>2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections</description>
    <arm_group_label>Bupivacaine/triamcinolone injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Superior laryngeal nerve block - Placebo (saline)</intervention_name>
    <description>2-cc injection of saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections</description>
    <arm_group_label>Saline injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking adults referred into or treated by the University of South Florida&#xD;
             department of Otolaryngology practice with chronic cough (including throat clearing&#xD;
             with globus) as determined by presence &gt; 8 weeks duration&#xD;
&#xD;
          -  Presumed to have neurogenic component based on history with no other obvious treatable&#xD;
             (and untreated) cause&#xD;
&#xD;
          -  refractory to proton pump inhibitor (PPI) therapy (at least 4 week trial)&#xD;
&#xD;
          -  no improvement of upper airway cough syndrome symptoms with medications if indicated&#xD;
             (eg, Flonase and antihistamine)&#xD;
&#xD;
          -  Patients may continue any medications for possibly related conditions (e.g., Flonase,&#xD;
             gabapentin, etc.) including allergies, chronic sinusitis, acid reflux; there should be&#xD;
             NO changes to mediation regimen within 1 months of study initiation (with the&#xD;
             exception of patients who were not previously on PPI that failed trail of PPI which&#xD;
             they will discontinue 1 month prior to first intervention)&#xD;
&#xD;
          -  Willingness to participant be assigned and adhere to the protocol. Participants must&#xD;
             be willing and able to consent to participate in the study, be willing to undergo&#xD;
             intervention or the placebo, and be willing to commit to adhere to the study protocol&#xD;
             for the duration of the trial (PPI trial if applicable, 2-4 visits, follow up&#xD;
             questionnaires, participate in cough suppression)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwilling to participate in protocol&#xD;
&#xD;
          -  allergic to Marcaine/lidocaine or predisposing condition to allergy&#xD;
&#xD;
          -  uncontrolled medical condition (this will be treated on a case by case basis using&#xD;
             clinical judgment of risks and the medical condition, with participants being excluded&#xD;
             who have conditions that may significantly increase the odds of having a serious or&#xD;
             life-threatening reaction)&#xD;
&#xD;
          -  pulmonary processes (including chronic obstructive pulmonary disease (chronic&#xD;
             obstructive pulmonary disease), bronchiectasis, non-asthmatic eosinophilic bronchitis,&#xD;
             structural abnormalities, etc.)&#xD;
&#xD;
          -  asthma (must have history of abnormal pulmonary function provocation testing)&#xD;
&#xD;
          -  structural abnormality laryngoscopy (this does not pertain to inflammatory findings)&#xD;
&#xD;
          -  immunocompromised&#xD;
&#xD;
          -  current smoker (&gt;1 cigarette in past month)&#xD;
&#xD;
          -  use of angiotensin converting enzyme inhibitor current or within past month&#xD;
&#xD;
          -  Vulnerable population: students, employees, socially or economically disadvantaged,&#xD;
             wards of the state, pregnant women, cognitively impaired adults, non-adults.&#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_contact>
    <last_name>Anthony J Grady, MD</last_name>
    <phone>(813) 974-5638</phone>
    <email>agrady@usf.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of South Florida South Tampa Clinic</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Grady, MD</last_name>
      <phone>813-974-4683</phone>
      <email>agrady@usf.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Simpson CB, Tibbetts KM, Loochtan MJ, Dominguez LM. Treatment of chronic neurogenic cough with in-office superior laryngeal nerve block. Laryngoscope. 2018 Aug;128(8):1898-1903. doi: 10.1002/lary.27201. Epub 2018 Apr 18.</citation>
    <PMID>29668037</PMID>
  </reference>
  <reference>
    <citation>Dhillon VK. Superior laryngeal nerve block for neurogenic cough: A case series. Laryngoscope Investig Otolaryngol. 2019 Jul 5;4(4):410-413. doi: 10.1002/lio2.292. eCollection 2019 Aug.</citation>
    <PMID>31453350</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 6, 2022</last_update_submitted>
  <last_update_submitted_qc>November 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Florida</investigator_affiliation>
    <investigator_full_name>Anthony Grady</investigator_full_name>
    <investigator_title>Principal investigator (physician)</investigator_title>
  </responsible_party>
  <keyword>Superior laryngeal nerve</keyword>
  <keyword>Neurogenic cough</keyword>
  <keyword>Nerve Block</keyword>
  <keyword>Idiopathic 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>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Triamcinolone diacetate</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/NCT04468542
org study id: STUDY001182
nct id: NCT04468542
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Prospective randomized placebo-controlled trial assessing the efficacy of superior laryngeal
      nerve block for adults with neurogenic cough refractory to proton pump inhibitor as
      determined by improvement in validated cough severity questionnaires before and after
      injection of Marcaine and Kenalog compared to placebo (saline injection).
Abbreviations/ Definitions: cough severity index (CSI), Cough quality of life questionnaire
      (CQLQ), proton pump inhibitor (PPI), nasopharyngolaryngoscopy (NPL), University of South
      Florida (USF), superior laryngeal nerve (SLN), upper airway cough syndrome (UACS), food and
      drug administration (FDA), investigational new drug (IND), medical record number (MRN),
      electronic medical record (EMR), ear nose and throat (ENT), angiotensin converting enzyme
      (ACE), chronic rhinosinusitis (CRS), gastroesophageal reflux disorder (GERD), pulmonary
      function test (PFT), Reflux finding score (RFS), Speech and language pathology (SLP)

      Participants will be referred into (via other USF affiliated departments) or recruited within
      the University of South Florida Department of Otolaryngology practice. Individuals will be
      screened for eligibility based on referral description. Eligibility will be determined by
      history at initial visit based on inclusion and exclusion criteria. Eligible participants
      will be adults with chronic cough >8 weeks duration and presumed neurogenic cough based on
      initial evaluation. Chronic throat clearing with foreign body sensation for >8 weeks duration
      will also meet criteria for inclusion and will be used synonymously with and considered
      chronic cough for the remainder of this protocol and study. Patients will be excluded if
      primary cause is determined to not be neurogenic. Patients will be excluded if there are
      other possible significant contributors to the cough that have not been treated (no other
      obvious treatable and untreated cause), or they will be treated per the standard of care
      prior to enrolling in this study. Patients will be screened for at least a 4-week course of
      PPI therapy during duration of symptoms. Patients with possible UACS were included if a trial
      of medications had been completed previously. If patients are on long term medications that
      are effective for their respective related condition (but still ineffective at adequately
      controlling chronic cough), they will be encouraged to make no unnecessary changes through
      treatment/study duration. These include acid suppression therapy (outside of the recent
      6-week trial of PPI if applicable), therapy for UACS symptoms if indicated (eg, Flonase and
      antihistamine, saline rinses, etc.), neuromodulators (e.g., gabapentin). Patients were
      excluded if they started any of these medications in last month and were not willing to
      discontinue them for the duration of the trial. Participants must be willing and able to
      consent to participate in the study, be willing to be assigned to and undergo intervention or
      the placebo, and be willing to adhere to the study protocol for the duration of the trial:
      2-4 visits, approximately 3 weeks of treatment, 6 week PPI trial with 4 week discontinuation
      period if no improvement (if applicable), up to 12 week follow up questionnaires (survey
      only), participate in cough suppression, take PPI as prescribed for duration specified.

      Participants were excluded if at any point they met the following criteria: unwilling to
      participate in protocol, allergic to Bupivacaine or triamcinolone acetonide suspension,
      presence of severe uncontrolled medical condition, any significant pulmonary processes
      (including chronic obstructive pulmonary disease, bronchiectasis, non-asthmatic eosinophilic
      bronchitis, structural abnormalities, etc.), presence of asthma (determined by presence of
      abnormal pulmonary function test (PFT) provocation testing), concern for aerodigestive tract
      malignancy from history or exam, structural abnormality seen on NPL or prior imaging,
      immunocompromised, current smoker, use of ACE inhibitor at time of or one month preceding
      first injection, or vulnerable population.

      Eligible participants underwent NPL will be also conducted at initial visit (Reflux finding
      score, RFS). Informed consent will be obtained at this time. Demographics (including sex,
      age, past medical history, related comorbidities, sidedness of globus sensation,
      neuromodulator use, results of any prior chest radiograph during symptom duration, ever
      referred to SLP for voice therapy) will be recorded at initial visit. Related comorbidities
      include UACS, allergic rhinitis, CRS, GERD. Patients who had not previously received adequate
      PPI trial were placed in 4 to 6-week course and encourage/counseled to complete lifestyle
      modifications to reduce reflux. Patients with less than complete response to PPI (persistent
      clinically significant cough) therapy were included in study. Patients follow-up visit for
      consideration of injection was schedule one month after discontinuing PPI trial.
      Questionnaire scores were determined immediately prior to first injection. All patients were
      counseled on cough suppression prior to initial injection. Patients were randomly assigned to
      placebo (2-cc normal saline) or intervention (total of 2-cc injection, mixture consisting of
      1-cc of Bupivacaine and 1-cc of Kenolog-40) injection groups using computer-generated random
      assignment. Injections will begin at initial visit or at follow-up visit if trial of PPI
      required. Immediately preceding injections, patients will be given 5 sprays of 4% topical
      lidocaine to facilitate injection which will also act to facilitate patient blinding.
      Injection will be delivered into the region of the proximal superior laryngeal nerve using
      greater cornu of hyoid and superior cornu of thyroid cartilage as landmarks. Injection will
      be placed 1-cm anterior to the midpoint of these landmarks.

      If globus sensation or trigger site was localized to one side, this was recorded and initial
      injection was directed at this side, otherwise this was picked at random. The second
      injection was directed at the same side if partial improvement (patient's subjective sense of
      least 50% reduction of symptoms) was observed after the first injection. The second injection
      was directed at the contralateral side if there was no initial improvement. Third injection
      was offered if there was improvement during either of the first two injections (completed on
      the ipsilateral side of prior two injections or the side with most improvement if bilateral
      had been completed). There was no second/third injection if complete resolution of symptoms
      was observed after the preceding injection. Follow up for repeat injection will be scheduled
      in 1-2 weeks, and exact time recorded. Questionnaire scores were then recorded 2 weeks after
      final injection of the series. Surveys (see next section, CSI and CQLQ) will also be sent for
      patients to complete at 6 and 12 weeks after last injection, which will be analyzed in
      subsequent study. Surveys will have a one-week window to be considered in their nominal
      category. All adverse events will be recorded. See data capture sheet for collected
      variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 2 week post-treatment cough severity index score improvement
time frame: Immediately pre-treatment and post-treatment at 2 weeks
description: Measure of efficacy of intervention by comparing change in pre-treatment and 2 week post-treatment cough severity index scores between intervention to placebo
measure: 2 week post-treatment cough-specific quality-of-life questionnaire score improvement
time frame: Immediately pre-treatment and post-treatment at 2 weeks
description: Measure of efficacy of intervention by comparing change in pre-treatment and 2 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo
measure: 6 week post-treatment cough severity index score improvement
time frame: Immediately pre-treatment and post-treatment at 6 weeks
description: Measure of efficacy of intervention by comparing change in pre-treatment and 6 week post-treatment cough severity index scores between intervention to placebo
measure: 12 week post-treatment cough severity index score improvement
time frame: Immediately pre-treatment and post-treatment at 12 weeks
description: Measure of efficacy of intervention by comparing change in pre-treatment and 12 week post-treatment cough severity index scores between intervention to placebo
measure: 6 week post-treatment cough-specific quality-of-life questionnaire score improvement
time frame: Immediately pre-treatment and post-treatment at 6 weeks
description: Measure of efficacy of intervention by comparing change in pre-treatment and 6 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo
measure: 12 week post-treatment cough-specific quality-of-life questionnaire score improvement
time frame: Immediately pre-treatment and post-treatment at 12 weeks
description: Measure of efficacy of intervention by comparing change in pre-treatment and 12 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo
arm group label: Bupivacaine/triamcinolone injection
arm group type: Experimental
description: 2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
arm group label: Saline injection
arm group type: Placebo Comparator
description: 2-cc injection of normal saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
intervention type: Drug
intervention name: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)
description: 2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
arm group label: Bupivacaine/triamcinolone injection
intervention type: Drug
intervention name: Superior laryngeal nerve block - Placebo (saline)
description: 2-cc injection of saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
arm group label: Saline injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony J Grady, MD
phone: (813) 974-5638
email: agrady@usf.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Simpson CB, Tibbetts KM, Loochtan MJ, Dominguez LM. Treatment of chronic neurogenic cough with in-office superior laryngeal nerve block. Laryngoscope. 2018 Aug;128(8):1898-1903. doi: 10.1002/lary.27201. Epub 2018 Apr 18.
PMID: 29668037
citation: Dhillon VK. Superior laryngeal nerve block for neurogenic cough: A case series. Laryngoscope Investig Otolaryngol. 2019 Jul 5;4(4):410-413. doi: 10.1002/lio2.292. eCollection 2019 Aug.
PMID: 31453350
responsible party type: Principal Investigator
investigator affiliation: University of South Florida
investigator full name: Anthony Grady
investigator title: Principal investigator (physician)
mesh term: Cough
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Bupivacaine
mesh term: Triamcinolone diacetate
sharing ipd: No