<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/NCT02203162</url>
  </required_header>
  <id_info>
    <org_study_id>2014-3288</org_study_id>
    <nct_id>NCT02203162</nct_id>
  </id_info>
  <brief_title>Effect of Electronic Cigarette Use on Cough Reflex Sensitivity</brief_title>
  <official_title>Effect of Electronic Cigarette Use on Cough Reflex Sensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although electronic cigarettes (e-cigs) are now widely used, very little information exists&#xD;
      regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim&#xD;
      of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30&#xD;
      seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes&#xD;
      after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will&#xD;
      consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate&#xD;
      nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5,&#xD;
      the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough&#xD;
      challenge studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cough Reflex Sensitivity (Log C5)</measure>
    <time_frame>Baseline, 15 minutes, and 24 hours post-exposure to e-cig.</time_frame>
    <description>Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cough</condition>
  <arm_group>
    <arm_group_label>cough reflex sensitivity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>electronic cigarette exposure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electronic cigarette exposure</intervention_name>
    <description>30 puffs of a disposable electronic cigarette, 30 seconds apart.</description>
    <arm_group_label>cough reflex sensitivity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults (age18 years and above)&#xD;
&#xD;
          -  nonsmokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous smoker&#xD;
&#xD;
          -  asthma/other respiratory illness&#xD;
&#xD;
          -  acute viral upper respiratory tract infection (common cold) in previous 4 weeks&#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>Peter V Dicpinigaitis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center and Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Einstein Division/Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.</citation>
    <PMID>26291648</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>January 22, 2016</results_first_submitted>
  <results_first_submitted_qc>April 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 4, 2016</results_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cough</keyword>
  <keyword>cough reflex sensitivity</keyword>
  <keyword>electronic cigarette</keyword>
  <keyword>capsaicin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cough</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results of this study have been published in January 2016 as a full manuscript.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Electronic Cigarette Exposure</title>
          <description>30 healthy subjects-adult nonsmokers</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>adult nonsmokers</population>
      <group_list>
        <group group_id="B1">
          <title>Subjects</title>
          <description>all subjects underwent cough challenge testing at baseline and after e-cig exposure</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>cough reflex sensitivity</title>
          <units>log C5</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.5" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Cough Reflex Sensitivity (Log C5)</title>
        <description>Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.</description>
        <time_frame>Baseline, 15 minutes, and 24 hours post-exposure to e-cig.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electronic Cigarette Exposure</title>
            <description>30 subjects-healthy adult nonsmokers</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cough Reflex Sensitivity (Log C5)</title>
          <description>Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.</description>
          <units>log C5</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change after 15 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" lower_limit="-0.43" upper_limit="-0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change after 24 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" lower_limit="0.10" upper_limit="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Subjects</title>
          <description>30 subjects-adult nonsmokers</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Peter Dicpinigaitis, MD</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>718-904-2676</phone>
      <email>pdicpini@montefiore.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02203162
org study id: 2014-3288
nct id: NCT02203162
lead sponsor: 
has dmc: No
Although electronic cigarettes (e-cigs) are now widely used, very little information exists
      regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim
      of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30
      seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.
30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes
      after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will
      consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate
      nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5,
      the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough
      challenge studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Cough Reflex Sensitivity (Log C5)
time frame: Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
description: Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
arm group label: cough reflex sensitivity
arm group type: Experimental
description: electronic cigarette exposure
intervention type: Device
intervention name: electronic cigarette exposure
description: 30 puffs of a disposable electronic cigarette, 30 seconds apart.
arm group label: cough reflex sensitivity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter V Dicpinigaitis, MD
role: Principal Investigator
affiliation: Montefiore Medical Center and Albert Einstein College of Medicine
facility: 
country: United States
citation: Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.
PMID: 26291648
responsible party type: Sponsor
mesh term: Cough
mesh term: Hypersensitivity
sharing ipd: No
ipd description: Results of this study have been published in January 2016 as a full manuscript.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 