<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/NCT03020667</url>
  </required_header>
  <id_info>
    <org_study_id>P1-PMC-01-JP</org_study_id>
    <nct_id>NCT03020667</nct_id>
  </id_info>
  <brief_title>Japanese Post-Market Cohort Study</brief_title>
  <official_title>An Observational Cohort Study in Japan to Assess the Patterns of Product Use and Changes in Health Outcomes Associated With the Use of HeatSticks With the IQOS Tobacco Heating System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philip Morris Products S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philip Morris Products S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives and endpoints of this study will be analyzed in the study population of adults&#xD;
      legally authorized to buy tobacco products. The study will describe the patterns of use of&#xD;
      tobacco and nicotine containing products and self-reported health outcomes and health related&#xD;
      events in CC (Cigarette) smokers and IQOS users in Japan.&#xD;
&#xD;
      Note: The initial study record (posted to ClinicalTrials.gov) included a clinical sub-study&#xD;
      designed to estimate population level differences in the biomarkers of exposure and clinical&#xD;
      risk endpoints between iQOS users, CC smokers and never-smokers. However, due to low&#xD;
      recruitment and retention of subjects, the clinical sub-study was terminated in May 2017 and&#xD;
      the main study was terminated in March 2018. The study protocol was updated to remove the&#xD;
      clinical sub-study objectives. This version of the study reflects the latest version of the&#xD;
      updated study protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, observational, open cohort study of adults, legally authorized to&#xD;
      purchase tobacco products in Japan. The study will describe the patterns of use of tobacco&#xD;
      and nicotine containing products and self-reported health outcomes in CC smokers and IQOS&#xD;
      users.&#xD;
&#xD;
      For IQOS users, the date of initiation of IQOS use is the trigger for all study assessments&#xD;
      in the study. However the process will be different for CC smokers for whom assessment timing&#xD;
      will be based on the date of enrollment. IQOS users will be enrolled into the study at least&#xD;
      two months after initiating use of IQOS (to ensure adoption of IQOS), but less than 12 months&#xD;
      after initiating use of IQOS. The study assessments will start at the next appropriate study&#xD;
      time point after enrollment.&#xD;
&#xD;
      As this study is observational by design and is conducted in a post-market setting, adverse&#xD;
      event (AE) reporting will follow the Sponsor's established post-market Safety Surveillance&#xD;
      Procedures for spontaneously reported events. IQOS users will be reminded of the product&#xD;
      quality complaints (including AEs) hotline that is available for all IQOS consumers in Japan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Actual">March 23, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Product consumption</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure the mean number of cigarettes smoked, IQOS HeatSticks used, and mean number of times of e-cigarettes used (per day and/or per week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Product use patterns</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure product use patterns over time (individual and dual/poly use patterns)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of product use</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure the rate of increase or decrease in product use over time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Product use trajectories</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure intra-individual product use trajectories (product switching, uptake of new products, and rate of tobacco and nicotine product use transitions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tobacco and nicotine-containing products cessation</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure rate of cessation from cigarette, tobacco, and nicotine-containing products</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motivations for quitting tobacco use</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure the rate and number of participants that want to quit and their reasons for quitting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attempts to quit tobacco use</measure>
    <time_frame>Study duration (up to 5 years)</time_frame>
    <description>To measure the rate and number of participants that attempt to quit and the characteristics of the quit attempts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Demographics of tobacco and nicotine-containing product users</measure>
    <time_frame>At baseline only</time_frame>
    <description>To record the demographics and socioeconomic characteristics of tobacco and nicotine-containing product users</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking History</measure>
    <time_frame>At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60</time_frame>
    <description>To record the smoking history of tobacco and nicotine-containing products users</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Product usage and behaviors (prior to IQOS use)</measure>
    <time_frame>At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60</time_frame>
    <description>To record tobacco and nicotine-containing product usage and behaviors, prior to IQOS use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Urge to Smoke</measure>
    <time_frame>At baseline, Month 3, Month 6, Month 9, and Month 12</time_frame>
    <description>Urge to Smoke measured by the QSU-brief (Questionnaire of Smoking Urges-brief)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective effects of IQOS use</measure>
    <time_frame>At baseline, Month 3, Month 6, Month 9, and Month 12, and Month 24</time_frame>
    <description>Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) in IQOS users.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported changes since switching to the product</measure>
    <time_frame>At baseline, Month 3, Month 6, Month 9, and Month 12.</time_frame>
    <description>Measured with the Self-Reported Changes Questionnaire (SRCQ) in IQOS users.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived risk</measure>
    <time_frame>At baseline, at Month 12, Month 24, Month 36, Month 48, and Month 60.</time_frame>
    <description>Perception of risk associated with using CC, IQOS and e-cigarettes measured with the Perceived Risk Instrument (PRI-P). Measured on a scale from 0 (no risk) to 4 (very high risk).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine dependence</measure>
    <time_frame>At baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24, Month 30, Month 36, Month 48, and Month 60</time_frame>
    <description>The level of nicotine dependence of the participants, measured by the Fagerstrom Test of Nicotine Dependence (FTND) scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease by product use</measure>
    <time_frame>At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60</time_frame>
    <description>Measured by number of self-reported signs, symptoms and diagnoses of disease by product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Self-reported health events</measure>
    <time_frame>At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60</time_frame>
    <description>Measured by recording the number of emergency room visits and/or hospitalizations, by product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in frequency and intensity of cough</measure>
    <time_frame>At baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24, Month 30, Month 36, Month 48, and Month 60</time_frame>
    <description>Measured on a Visual Analogue Scale (VAS) of 0 (not bothering me at all) to 10 (very bothersome).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1124</enrollment>
  <condition>Smoking</condition>
  <condition>Tobacco Product</condition>
  <arm_group>
    <arm_group_label>IQOS Users</arm_group_label>
    <description>The criteria defining an &quot;IQOS user&quot; are listed in the section &quot;Eligibility&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cigarette (CC) Smokers</arm_group_label>
    <description>The criteria defining a &quot;CC smoker&quot; are listed in the section &quot;Eligibility&quot;.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A minimum of 4000 adults (female or male) will be enrolled into this study, including 2000&#xD;
        IQOS users and 2000 CC smokers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult tobacco users in Japan (20 years of age)&#xD;
&#xD;
          -  The participant is Japanese&#xD;
&#xD;
          -  Participant is able to understand the information provided in the Informed Consent&#xD;
             form (ICF)&#xD;
&#xD;
          -  Signed ICF&#xD;
&#xD;
          -  Willing to participate in the study and has access to the internet&#xD;
&#xD;
          -  For IQOS users:&#xD;
&#xD;
               -  Is currently using IQOS HeatSticks&#xD;
&#xD;
               -  Has used at least 100 IQOS HeatSticks in their lifetime, and&#xD;
&#xD;
               -  Has used IQOS HeatSticks for 2 months or more&#xD;
&#xD;
          -  For CC smokers:&#xD;
&#xD;
               -  Is currently using CC&#xD;
&#xD;
               -  Is not currently using IQOS HeatSticks, and&#xD;
&#xD;
               -  Has used at least 100 CC in their lifetime&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tobacco industry employees&#xD;
&#xD;
          -  Employed by the Sponsor, CRO or Clinical Site&#xD;
&#xD;
          -  For IQOS users:&#xD;
&#xD;
               -  More than 12 months of IQOS use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kunihiko Uwatoko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uwatoko Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis Prieto, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Philip Morris Products S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uwatoko Clinic</name>
      <address>
        <city>Ozone</city>
        <state>Nagoya</state>
        <zip>462-0825</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cigarette</keyword>
  <keyword>IQOS</keyword>
  <keyword>Nicotine-containing product</keyword>
  <keyword>Tobacco</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 8, 2019</submitted>
    <returned>June 28, 2019</returned>
  </pending_results>
  <!-- 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/NCT03020667
org study id: P1-PMC-01-JP
nct id: NCT03020667
lead sponsor: 
has dmc: No
The objectives and endpoints of this study will be analyzed in the study population of adults
      legally authorized to buy tobacco products. The study will describe the patterns of use of
      tobacco and nicotine containing products and self-reported health outcomes and health related
      events in CC (Cigarette) smokers and IQOS users in Japan.

      Note: The initial study record (posted to ClinicalTrials.gov) included a clinical sub-study
      designed to estimate population level differences in the biomarkers of exposure and clinical
      risk endpoints between iQOS users, CC smokers and never-smokers. However, due to low
      recruitment and retention of subjects, the clinical sub-study was terminated in May 2017 and
      the main study was terminated in March 2018. The study protocol was updated to remove the
      clinical sub-study objectives. This version of the study reflects the latest version of the
      updated study protocol.
This is a prospective, observational, open cohort study of adults, legally authorized to
      purchase tobacco products in Japan. The study will describe the patterns of use of tobacco
      and nicotine containing products and self-reported health outcomes in CC smokers and IQOS
      users.

      For IQOS users, the date of initiation of IQOS use is the trigger for all study assessments
      in the study. However the process will be different for CC smokers for whom assessment timing
      will be based on the date of enrollment. IQOS users will be enrolled into the study at least
      two months after initiating use of IQOS (to ensure adoption of IQOS), but less than 12 months
      after initiating use of IQOS. The study assessments will start at the next appropriate study
      time point after enrollment.

      As this study is observational by design and is conducted in a post-market setting, adverse
      event (AE) reporting will follow the Sponsor's established post-market Safety Surveillance
      Procedures for spontaneously reported events. IQOS users will be reminded of the product
      quality complaints (including AEs) hotline that is available for all IQOS consumers in Japan.
observational model: Cohort
time perspective: Prospective
measure: Product consumption
time frame: Study duration (up to 5 years)
description: To measure the mean number of cigarettes smoked, IQOS HeatSticks used, and mean number of times of e-cigarettes used (per day and/or per week)
measure: Product use patterns
time frame: Study duration (up to 5 years)
description: To measure product use patterns over time (individual and dual/poly use patterns)
measure: Rate of product use
time frame: Study duration (up to 5 years)
description: To measure the rate of increase or decrease in product use over time
measure: Product use trajectories
time frame: Study duration (up to 5 years)
description: To measure intra-individual product use trajectories (product switching, uptake of new products, and rate of tobacco and nicotine product use transitions
measure: Tobacco and nicotine-containing products cessation
time frame: Study duration (up to 5 years)
description: To measure rate of cessation from cigarette, tobacco, and nicotine-containing products
measure: Motivations for quitting tobacco use
time frame: Study duration (up to 5 years)
description: To measure the rate and number of participants that want to quit and their reasons for quitting.
measure: Attempts to quit tobacco use
time frame: Study duration (up to 5 years)
description: To measure the rate and number of participants that attempt to quit and the characteristics of the quit attempts.
measure: Demographics of tobacco and nicotine-containing product users
time frame: At baseline only
description: To record the demographics and socioeconomic characteristics of tobacco and nicotine-containing product users
measure: Smoking History
time frame: At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60
description: To record the smoking history of tobacco and nicotine-containing products users
measure: Product usage and behaviors (prior to IQOS use)
time frame: At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60
description: To record tobacco and nicotine-containing product usage and behaviors, prior to IQOS use
measure: Change in Urge to Smoke
time frame: At baseline, Month 3, Month 6, Month 9, and Month 12
description: Urge to Smoke measured by the QSU-brief (Questionnaire of Smoking Urges-brief)
measure: Subjective effects of IQOS use
time frame: At baseline, Month 3, Month 6, Month 9, and Month 12, and Month 24
description: Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) in IQOS users.
measure: Self-reported changes since switching to the product
time frame: At baseline, Month 3, Month 6, Month 9, and Month 12.
description: Measured with the Self-Reported Changes Questionnaire (SRCQ) in IQOS users.
measure: Perceived risk
time frame: At baseline, at Month 12, Month 24, Month 36, Month 48, and Month 60.
description: Perception of risk associated with using CC, IQOS and e-cigarettes measured with the Perceived Risk Instrument (PRI-P). Measured on a scale from 0 (no risk) to 4 (very high risk).
measure: Nicotine dependence
time frame: At baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24, Month 30, Month 36, Month 48, and Month 60
description: The level of nicotine dependence of the participants, measured by the Fagerstrom Test of Nicotine Dependence (FTND) scale.
measure: Disease by product use
time frame: At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60
description: Measured by number of self-reported signs, symptoms and diagnoses of disease by product use.
measure: Change in Self-reported health events
time frame: At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60
description: Measured by recording the number of emergency room visits and/or hospitalizations, by product use.
measure: Change in frequency and intensity of cough
time frame: At baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24, Month 30, Month 36, Month 48, and Month 60
description: Measured on a Visual Analogue Scale (VAS) of 0 (not bothering me at all) to 10 (very bothersome).
arm group label: IQOS Users
description: The criteria defining an "IQOS user" are listed in the section "Eligibility".
arm group label: Cigarette (CC) Smokers
description: The criteria defining a "CC smoker" are listed in the section "Eligibility".
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kunihiko Uwatoko, MD
role: Principal Investigator
affiliation: Uwatoko Clinic
last name: Luis Prieto, PhD
role: Study Chair
affiliation: Philip Morris Products S.A.
facility: 
country: Japan
responsible party type: Sponsor
sharing ipd: No
submitted: April 8, 2019
returned: June 28, 2019