Clinical trial NCT03020667: Japanese Post-Market Cohort Study
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Smoking
Tobacco Product
Keywords: Cigarette
IQOS
Nicotine-containing product
Tobacco
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 1124
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (female or male) Japanese IQOS users and CC smokers.

Brief summary: The objectives and endpoints of this study were analyzed in the study population of adults eligible to purchase tobacco products. The study was planned to 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.

The initial study record (posted on ClinicalTrials.gov) included a clinical sub-study designed to estimate population level differences in the biomarkers of exposure and clinical risk endpoints among 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 for the same reasons the main study was terminated in March 2018. The study protocol was updated to remove the clinical sub-study objectives. The study initially included 18 outcome measures. Due to study termination leading to a shortened follow-up period and a smaller sample size, only 7 of these outcome measures could be assessed and the other outcome measures planned were either unattainable or uninformative.

Detailed description: This was a prospective, observational, cohort study of adults, eligible to purchase tobacco products in Japan. The study described the patterns of use of tobacco and nicotine containing products in CC smokers and IQOS users.

For IQOS users, the date of initiation of IQOS use was the trigger for all study assessments in the study. However the process was different for CC smokers for whom assessment timing was based on the date of enrollment. IQOS users were 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 started at the next appropriate study time point after enrollment. Participants were recruited from consumer databases and/or through advertisement. Responses from all eligible participants in the study were collected online using computer assisted self-interviews (CASIs). The questionnaires included demographic information, tobacco use questionnaire including detailed product use and intention to stop tobacco- and nicotine-containing product use, lifestyle assessments, social-economic status, risk perception, nicotine dependence, urge to smoke, as well as self-reported health outcomes. IQOS users were also administered the Modified Cigarette Evaluation Questionnaire, and Self-Reported Changes Questionnaire. The CASIs were administered at the enrollment and quarterly for the first 18 months (at Months 3, 6, 9, 12, 15 and 18).

The study initially was planned to recruit 2,000 IQOS users and 2,000 cigarette (CC) smokers in 4 annual waves (500 IQOS users and 500 CC smokers per wave) and to be followed up to a maximum of 60 months. The first wave of recruitment competed in March 2017. During wave 2 recruitment the study was terminated. A total of 599 IQOS users and 525 CC smokers were enrolled. There was 1 reported protocol deviation in IQOS users, the participant had been using IQOS for 15 months. Due to study termination, only data collected for wave 1 was analyzed.

As this study was observational by design and was conducted in a post-market setting, adverse event (AE) reporting followed the Sponsor's established post-market Safety Surveillance Procedures for spontaneously reported events. IQOS users were reminded of the product quality complaints (including AEs) hotline that is available for all IQOS consumers in Japan.

Eligibility criteria: Inclusion Criteria:

* Adult tobacco users in Japan (at least 20 years of age)
* The participant is Japanese
* Participant is able to understand the information provided in the Informed Consent form (ICF)
* Signed ICF
* Willing to participate in the study and has access to the internet
* For IQOS users:

  * Is currently using IQOS with HeatSticks
  * Has used at least 100 HeatSticks with IQOS in their lifetime, and
  * Has used IQOS with HeatSticks for 2 months or more
* For CC smokers:

  * Is currently using CC
  * Is not currently using IQOS with HeatSticks, and
  * Has used at least 100 CC in their lifetime

Exclusion Criteria:

* Tobacco industry employees
* Employed by the Sponsor, CRO or Clinical Site
* For IQOS users:

  * More than 12 months of IQOS use

Primary outcomes:
measure: Product Consumption
timeFrame: CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time
measure: Product Use Patterns
timeFrame: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up
measure: Rate of Product Use
timeFrame: IQOS users: 3-18 months IQOS use time
measure: Tobacco and Nicotine-containing Products Cessation
timeFrame: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up
measure: Demographics of Tobacco and Nicotine-containing Product Users
timeFrame: IQOS users at enrollment
measure: Smoking History (Duration)
timeFrame: At enrollment
measure: Smoking History (Intensity)
timeFrame: At enrollment
measure: Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration
timeFrame: From enrollment up to 15 months follow-up
measure: Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity
timeFrame: From enrollment up to 15 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ozone
country: Japan
facility: Uwatoko Clinic
state: Nagoya
Study officials:
affiliation: Uwatoko Clinic
name: Kunihiko Uwatoko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philip Morris Products S.A.
name: Pierpaolo Magnani
role: STUDY_CHAIR
References: