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The study was terminated due to excessive attrition rates.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQOS Users | The criteria defining an "IQOS user" are listed in the section "Eligibility". | ||
| Cigarette (CC) Smokers | The criteria defining a "CC smoker" are listed in the section "Eligibility". |
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| Measure | Description | Time Frame |
|---|---|---|
| Product Consumption | To measure the mean numbers of cigarettes smoked and IQOS with HeatSticks used, mean numbers/times of Other Tobacco and Nicotine containing Products (OTP) used. OTP: included all other tobacco and nicotine-containing products except IQOS. | CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time |
| Product Use Patterns | To describe product use patterns in CC smokers and IQOS users by product use categories. Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-User/smoker: Total consumption of all products = 0, Other: Does not fit in any of the above categories and no 'missing'. | IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up |
| Rate of Product Use | To measure the percentage of product use in IQOS users based on IQOS use time.
| IQOS users: 3-18 months IQOS use time |
| Tobacco and Nicotine-containing Products Cessation | To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users | IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up |
| Demographics of Tobacco and Nicotine-containing Product Users | To describe the demographics characteristics of IQOS users by product use category: Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-Use: Total consumption of all products= 0, Other: Does not fit in any of the above categories and no 'missing'. |
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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:
For CC smokers:
Exclusion Criteria:
Tobacco industry employees
Employed by the Sponsor, CRO or Clinical Site
For IQOS users:
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Adults (female or male) Japanese IQOS users and CC smokers.
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| Name | Affiliation | Role |
|---|---|---|
| Kunihiko Uwatoko, MD | Uwatoko Clinic | Principal Investigator |
| Pierpaolo Magnani | Philip Morris Products S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uwatoko Clinic | Ōzone | Nagoya | 462-0825 | Japan |
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CC smokers: based on the date of enrollment. IQOS users: based on date of initiation of IQOS use (IQOS use time).
525 CC smokers and 599 IQOS users were enrolled, 70 IQOS users initiated IQOS 3 months ago, 191 IQOS users initiated IQOS 6 months ago, 264 IQOS users initiated IQOS 9 months ago, 73 IQOS users initiated IQOS 12 months ago, and 1 IQOS user initiated IQOS 15 month ago.
Note: only data collected of wave 1 participants was analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | CC Smokers | The criteria defining a "CC smoker" are listed in the section "Eligibility". |
| FG001 | IQOS Users: 3 Months IQOS Use Time | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| FG002 | IQOS Users: 6 Months IQOS Use Time | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| FG003 | IQOS Users: 9 Months IQOS Use Time | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| FG004 | IQOS Users 12 Months IQOS Use Time | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| FG005 | IQOS Users 15 Months IQOS Use Time | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At Month 3 |
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| At Month 6 |
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| At Month 9 |
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| At Month 12 |
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| At Month 15 |
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| At Month 18 |
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Adult Japanese CC smokers or IQOS users
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| ID | Title | Description |
|---|---|---|
| BG000 | CC Smokers | The criteria defining a "CC smoker" are listed in the section "Eligibility". |
| BG001 | IQOS Users | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Product Consumption | To measure the mean numbers of cigarettes smoked and IQOS with HeatSticks used, mean numbers/times of Other Tobacco and Nicotine containing Products (OTP) used. OTP: included all other tobacco and nicotine-containing products except IQOS. | CC smokers: at enrollment, IQOS users: 3-18 months IQOS use time | Posted | Mean | Standard Deviation | number of consumption per day | CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time |
|
15 Months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All subjects that participated in the study. | 0 |
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Due to study termination leading to a shortened follow-up period and a smaller sample size, only 7 outcome measures could be assessed and the other outcome measures originally planned were either unattainable or uninformative.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kunihiko Uwatoko, MD | Uwatoko Clinic | +81-52-991-4602 | uwatoko.clinic@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2017 | Mar 27, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2018 | Mar 27, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| IQOS users at enrollment |
| Smoking History (Duration) | To record the smoking history (duration) in CC smokers and IQOS users, measured in years. | At enrollment |
| Smoking History (Intensity) | To record the smoking history (intensity) in CC smokers and IQOS users, measured in pack-years. One pack year is equivalent to smoking 20 cigarettes a day for one year. | At enrollment |
| Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration | To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years. | From enrollment up to 15 months follow-up |
| Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity | To measure smoking intensity among CC smokers who started to use IQOS during follow-up, measured in pack years. One pack year is equivalent to smoking 20 cigarettes a day for one year. | From enrollment up to 15 months follow-up |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | IQOS Users: 9 Months IQOS Use | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| OG003 | IQOS Users: 12 Months IQOS Use | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| OG004 | IQOS Users: 15 Months IQOS Use | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| OG005 | IQOS Users: 18 Months IQOS Use | The criteria defining a "IQOS user" are listed in the section "Eligibility". |
| OG006 | CC Smokers | The criteria defining a "CC smoker" are listed in the section "Eligibility". |
|
|
| Primary | Product Use Patterns | To describe product use patterns in CC smokers and IQOS users by product use categories. Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-User/smoker: Total consumption of all products = 0, Other: Does not fit in any of the above categories and no 'missing'. | IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up | Posted | Count of Participants | Participants | IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up |
|
|
|
| Primary | Rate of Product Use | To measure the percentage of product use in IQOS users based on IQOS use time.
| IQOS users: 3-18 months IQOS use time | Posted | Mean | Standard Deviation | percentage | IQOS users: 3-18 months IQOS use time |
|
|
|
| Primary | Tobacco and Nicotine-containing Products Cessation | To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users | IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up | Posted | Count of Participants | Participants | IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up |
|
|
|
| Primary | Demographics of Tobacco and Nicotine-containing Product Users | To describe the demographics characteristics of IQOS users by product use category: Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-Use: Total consumption of all products= 0, Other: Does not fit in any of the above categories and no 'missing'. | IQOS users at enrollment | Posted | Count of Participants | Participants | IQOS users at enrollment |
|
|
|
| Primary | Smoking History (Duration) | To record the smoking history (duration) in CC smokers and IQOS users, measured in years. | CC smokers and IQOS users at enrollment | Posted | Mean | Standard Deviation | years | At enrollment |
|
|
|
| Primary | Smoking History (Intensity) | To record the smoking history (intensity) in CC smokers and IQOS users, measured in pack-years. One pack year is equivalent to smoking 20 cigarettes a day for one year. | CC smokers and IQOS users at enrollment | Posted | Mean | Standard Deviation | pack years | At enrollment |
|
|
|
| Primary | Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration | To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years. | CC smokers who started to use IQOS during follow-up | Posted | Mean | Standard Deviation | years | From enrollment up to 15 months follow-up |
|
|
|
| Primary | Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity | To measure smoking intensity among CC smokers who started to use IQOS during follow-up, measured in pack years. One pack year is equivalent to smoking 20 cigarettes a day for one year. | CC smokers who started to use IQOS during follow-up | Posted | Mean | Standard Deviation | pack years | From enrollment up to 15 months follow-up |
|
|
|
| 1,124 |
| 0 |
| 1,124 |
| 0 |
| 1,124 |
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| Primarily CC (≥70% consumption of CC ) |
|
| Mixed IQOS-CC (IQOS and CC use in 30% to 70%) |
|
| Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) |
|
| Mixed CC-OTP (CC and OTP use in 30% to 70%) |
|
| Non-user/Smoker |
|
| Other |
|
| missing |
|
| %OTP |
|
| %IQOS |
|
| 20-29 years of age |
|
| 30-39 years of age |
|
| 40-49 years of age |
|
| 50-59 years of age |
|
| 60-69 years of age |
|
| 70-79 years of age |
|