<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/NCT03251053</url>
  </required_header>
  <id_info>
    <org_study_id>1251.09</org_study_id>
    <nct_id>NCT03251053</nct_id>
  </id_info>
  <brief_title>Adverse Airway Effects From Tobacco and E-Cigarettes</brief_title>
  <official_title>Adverse Airway Effects of Inhaled Nicotine From Tobacco and E-Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miami VA Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Miami VA Healthcare System</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking&#xD;
      electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative&#xD;
      effects than regular cigarettes on the person's respiratory health. We will assess this by&#xD;
      measuring pulmonary function tests, several body molecules and functionality of the airway&#xD;
      cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use.&#xD;
&#xD;
      In this study, some people will continue to smoke regular tobacco cigarettes while others&#xD;
      will switch to a nicotine-containing electronic cigarette.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate the airway epithelial effects of EC (electronic cigarettes) vapor&#xD;
      containing nicotine when used as a tobacco replacement tool. By using active cigarette&#xD;
      smokers as a comparator group, the study will increase our knowledge of whether the use of&#xD;
      ECs is more or less harmful than continuation of tobacco smoking. This study will examine the&#xD;
      in vivo effects of EC vapors in nasal ion transport and TGF-β levels as well as in serum&#xD;
      inflammatory biomarkers.&#xD;
&#xD;
      As the primary endpoint, nasal ion transport will be assessed by nasal potential difference&#xD;
      (NPD), which measures the voltage potential resulting from epithelial ion fluxes at the&#xD;
      mucosal surface in vivo. Ion transport across nasal epithelia is representative for findings&#xD;
      in distal airways. Since NPD directly measures the changes in ion transport expected to&#xD;
      influence mucociliary clearance (MCC) and therefore overall outcome and since changes of NPD&#xD;
      measurements are indirectly linked to lung function changes and MCC in trials with cystic&#xD;
      fibrosis patients, we believe that NPD lends itself as a reasonable surrogate for MCC for&#xD;
      this clinical trial.&#xD;
&#xD;
      As secondary endpoints, we will also measure TGF-ß levels in nasal secretions and expression&#xD;
      in nasal cells to correlate these with the level of CFTR and CaCC-mediated Cl- conductance&#xD;
      (CFTR is known to show decreased function with elevated TGF-β). In addition plasma samples&#xD;
      will be collected to study systemic markers of inflammation as well as toxic substances that&#xD;
      may result from vaping and smoking.&#xD;
&#xD;
      The design is a smoking replacement trial, in which we will compare changes in upper airway&#xD;
      ion transport and inflammation in smokers who switch to EC vaping versus subjects that&#xD;
      continue to smoke tobacco cigarettes. In addition, we will use the trial design to evaluate&#xD;
      the feasibility of using the EC as a means to quit tobacco use.&#xD;
&#xD;
      The study will last up to16 weeks with weekly visits. Subjects must replace completely&#xD;
      cigarettes with EC within the first 4 visits (week 4) and maintain exclusive use for the&#xD;
      following 12 visits. Adherence is asses with exhaled carbon monoxide and/or carboxyhemoglobin&#xD;
      when needed. The study involves scheduled blood draws for research samples.&#xD;
&#xD;
      There will be total of 16 visits to the study clinic. Besides blood draws and NPD, the study&#xD;
      will include questionnaires, lung function testing and adverse event recording.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 28, 2016</start_date>
  <completion_date type="Anticipated">March 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nasal potential difference (NPD)</measure>
    <time_frame>11 weeks of transitioning</time_frame>
    <description>nasal potential difference (NPD) before and after replacing tobacco cigarettes with electronic cigarettes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Inflammatory markers smoking to electronic cigarettes</measure>
    <time_frame>11 weeks of transitioning</time_frame>
    <description>TGF-ß levels in nasal secretions before and after replacing tobacco cigarettes with electronic cigarettes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Airway Morbidity</condition>
  <condition>Smoking Cessation</condition>
  <condition>Nicotine Adverse Reaction</condition>
  <condition>Smoking, Tobacco</condition>
  <condition>Smoking, Cigarette</condition>
  <arm_group>
    <arm_group_label>Electronic cigarette use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who try to switch to electronic cigarettes (EC) and subjects who successfully switch to EC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control regular cigarette smokers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Habitual smokers without EC use</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic cigarette use</intervention_name>
    <description>Replacement of tobacco smoking with electronic cigarette vaping</description>
    <arm_group_label>Control regular cigarette smokers</arm_group_label>
    <arm_group_label>Electronic cigarette use</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control regular cigarette smokers</intervention_name>
    <arm_group_label>Control regular cigarette smokers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects that actively smoke and have a history of at least 5 pack-years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV,marijuana use, asthma and other concomitant inflammatory pulmonary disorders,&#xD;
             subjects with known pulmonary diseases including malignancies, subjects with prior&#xD;
             thoracic surgery and subjects that used oral corticosteroids or antibiotics within the&#xD;
             prior 3 months, subjects with allergies to study medications and subjects incapable of&#xD;
             providing informed consent.&#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>Michael Campos</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miami VA Healthcare System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Campos, MD</last_name>
    <email>mcampos1@med.miami.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Guerrero</last_name>
    <email>amg475@miami.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Miami VA Healthcare System</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Campos, MD</last_name>
      <email>MCampos1@med.miami.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Miami VA Healthcare System</investigator_affiliation>
    <investigator_full_name>Michael Campos</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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/NCT03251053
org study id: 1251.09
nct id: NCT03251053
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking
      electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative
      effects than regular cigarettes on the person's respiratory health. We will assess this by
      measuring pulmonary function tests, several body molecules and functionality of the airway
      cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use.

      In this study, some people will continue to smoke regular tobacco cigarettes while others
      will switch to a nicotine-containing electronic cigarette.
The study will evaluate the airway epithelial effects of EC (electronic cigarettes) vapor
      containing nicotine when used as a tobacco replacement tool. By using active cigarette
      smokers as a comparator group, the study will increase our knowledge of whether the use of
      ECs is more or less harmful than continuation of tobacco smoking. This study will examine the
      in vivo effects of EC vapors in nasal ion transport and TGF-β levels as well as in serum
      inflammatory biomarkers.

      As the primary endpoint, nasal ion transport will be assessed by nasal potential difference
      (NPD), which measures the voltage potential resulting from epithelial ion fluxes at the
      mucosal surface in vivo. Ion transport across nasal epithelia is representative for findings
      in distal airways. Since NPD directly measures the changes in ion transport expected to
      influence mucociliary clearance (MCC) and therefore overall outcome and since changes of NPD
      measurements are indirectly linked to lung function changes and MCC in trials with cystic
      fibrosis patients, we believe that NPD lends itself as a reasonable surrogate for MCC for
      this clinical trial.

      As secondary endpoints, we will also measure TGF-ß levels in nasal secretions and expression
      in nasal cells to correlate these with the level of CFTR and CaCC-mediated Cl- conductance
      (CFTR is known to show decreased function with elevated TGF-β). In addition plasma samples
      will be collected to study systemic markers of inflammation as well as toxic substances that
      may result from vaping and smoking.

      The design is a smoking replacement trial, in which we will compare changes in upper airway
      ion transport and inflammation in smokers who switch to EC vaping versus subjects that
      continue to smoke tobacco cigarettes. In addition, we will use the trial design to evaluate
      the feasibility of using the EC as a means to quit tobacco use.

      The study will last up to16 weeks with weekly visits. Subjects must replace completely
      cigarettes with EC within the first 4 visits (week 4) and maintain exclusive use for the
      following 12 visits. Adherence is asses with exhaled carbon monoxide and/or carboxyhemoglobin
      when needed. The study involves scheduled blood draws for research samples.

      There will be total of 16 visits to the study clinic. Besides blood draws and NPD, the study
      will include questionnaires, lung function testing and adverse event recording.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in nasal potential difference (NPD)
time frame: 11 weeks of transitioning
description: nasal potential difference (NPD) before and after replacing tobacco cigarettes with electronic cigarettes
measure: change in Inflammatory markers smoking to electronic cigarettes
time frame: 11 weeks of transitioning
description: TGF-ß levels in nasal secretions before and after replacing tobacco cigarettes with electronic cigarettes
arm group label: Electronic cigarette use
arm group type: Experimental
description: Subjects who try to switch to electronic cigarettes (EC) and subjects who successfully switch to EC.
arm group label: Control regular cigarette smokers
arm group type: Other
description: Habitual smokers without EC use
intervention type: Device
intervention name: Electronic cigarette use
description: Replacement of tobacco smoking with electronic cigarette vaping
arm group label: Control regular cigarette smokers
arm group label: Electronic cigarette use
intervention type: Other
intervention name: Control regular cigarette smokers
arm group label: Control regular cigarette smokers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Campos
role: Principal Investigator
affiliation: Miami VA Healthcare System
last name: Michael Campos, MD
email: mcampos1@med.miami.edu
last name: Andrea Guerrero
email: amg475@miami.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Miami VA Healthcare System
investigator full name: Michael Campos
investigator title: MD
sharing ipd: No