SmokingNCT03020667

Japanese Post-Market Cohort Study

An observational study of Smoking and Tobacco Product, run by Philip Morris Products S.A. at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco Product
How many people: 1,124 participants
Where: 1 siteJapan
Study dates: Apr 2016to 30 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Adults (female or male) Japanese IQOS users and CC smokers.

Who may be able to join

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:

Show all 13Show fewer

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

Who cannot join

Tobacco industry employees
Employed by the Sponsor, CRO or Clinical Site
For IQOS users:
More than 12 months of IQOS use

Trial locations and contacts

1 site in 1 country.

Japan1 site

Uwatoko Clinic
Ōzone, Nagoya, 462-0825

Other trials in Japan

About this 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

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.

Read the 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.

Conditions: Smoking, Tobacco Product
Keywords: Cigarette, IQOS, Nicotine-containing product, Tobacco
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03020667
Study group	Role	What they receive
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".

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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'.
Measured: 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.
- IQOSi = percentage of IQOS use at time point i,
- CCi = percentage of CC use at time point i,
- OTPi = percentage of other tobacco products (OTP) use at time point i.
Measured: 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
Measured: 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'.
Measured: IQOS users at enrollment
Smoking History (Duration)
To record the smoking history (duration) in CC smokers and IQOS users, measured in years.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment up to 15 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201630 May 2018

First posted13 Jan 2017 (estimated)
Study startApr 2016
Primary completion23 Mar 2018
Study completion30 May 2018

Why it stopped: The study was terminated due to excessive attrition rates.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03020667
Sponsor's protocol ID: P1-PMC-01-JP
Status last verified: May 2024
First submitted: 17 Nov 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03020667
Acronym / sponsor ID: P1-PMC-01-JP
Conditions: Smoking, Tobacco Product
Keywords: Cigarette, IQOS, Nicotine-containing product, Tobacco
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was terminated due to excessive attrition rates.
Enrolment: 1,124 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: 23 Mar 2018 (actual)
Study completion: 30 May 2018 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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".

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adults (female or male) Japanese IQOS users and CC smokers.

Key inclusion criteria (13 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Product Consumption
Time frame: CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time
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.
Product Use Patterns
Time frame: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up
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'.
Rate of Product Use
Time frame: IQOS users: 3-18 months IQOS use time
To measure the percentage of product use in IQOS users based on IQOS use time. * IQOSi = percentage of IQOS use at time point i, * CCi = percentage of CC use at time point i, * OTPi = percentage of other tobacco products (OTP) use at time point i.
Tobacco and Nicotine-containing Products Cessation
Time frame: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up
To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users
Demographics of Tobacco and Nicotine-containing Product Users
Time frame: IQOS users at enrollment
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'.
Smoking History (Duration)
Time frame: At enrollment
To record the smoking history (duration) in CC smokers and IQOS users, measured in years.
Smoking History (Intensity)
Time frame: At enrollment
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.
Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration
Time frame: From enrollment up to 15 months follow-up
To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.
Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity
Time frame: From enrollment up to 15 months follow-up
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.

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CC Smokers	525	215
IQOS Users: 3 Months IQOS Use Time	70	70
IQOS Users: 6 Months IQOS Use Time	0	0
IQOS Users: 9 Months IQOS Use Time	0	0
IQOS Users 12 Months IQOS Use Time	0	0
IQOS Users 15 Months IQOS Use Time	0	0

Primary outcome: Product Consumption

Time frame: CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time. Mean (Standard Deviation). Unit: number of consumption per day

Measure	IQOS Users: 3 Months IQOS Use n = 66	IQOS Users: 6 Months IQOS Use n = 214	IQOS Users: 9 Months IQOS Use n = 375	IQOS Users: 12 Months IQOS Use n = 289	IQOS Users: 15 Months IQOS Use n = 161	IQOS Users: 18 Months IQOS Use n = 84	CC Smokers n = 460
Mean number of cigarettes smoked per day	4.0 (7.72)	3.8 (6.68)	4.6 (7.99)	4.4 (8.12)	5.1 (8.80)	4.0 (8.06)	15.8 (9.43)
Mean number of Heatsticks used per day	13.3 (8.85)	13.2 (7.75)	13.3 (8.52)	13.8 (8.68)	12.7 (8.61)	12.6 (8.69)	0.2 (1.93)
Mean number/times of OTP used per day	1.8 (6.00)	2.0 (5.41)	2.6 (7.97)	2.5 (7.41)	2.3 (6.33)	2.5 (5.84)	0.5 (2.18)

Population analysed: CC smokers: at enrollment, IQOS users: 3-18 months IQOS use time

Primary outcome: Product Use Patterns

Time frame: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up. Count of participants. Unit: Participants

Measure	IQOS Users: 3 Months IQOS Use n = 70	IQOS Users: 6 Months IQOS Use n = 241	IQOS Users: 9 Months IQOS Use n = 419	IQOS Users: 12 Months IQOS Use n = 310	IQOS Users: 15 Months IQOS Use n = 158	IQOS Users: 18 Months IQOS Use n = 84	CC Smokers Enrollment n = 525	CC Smokers After 3 Months Follow-up n = 215	CC Smokers After 6 Months Follow-up n = 107	CC Smokers After 9 Months Follow-up n = 12	CC Smokers After 12 Months Follow-up n = 4	CC Smokers After 15 Months Follow-up n = 1
Primarily IQOS (≥70% consumption of IQOS)	45	133	228	182	94	47	2	8	6	2	1	0
Primarily CC (≥70% consumption of CC )	8	16	44	36	26	15	430	204	91	10	3	1
Mixed IQOS-CC (IQOS and CC use in 30% to 70%)	6	29	46	30	15	4	2	2	0	0	0	0
Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%)	1	15	22	13	11	12	0	1	1	0	0	0
Mixed CC-OTP (CC and OTP use in 30% to 70%)	2	4	8	4	3	1	16	7	3	0	0	0
Non-user/Smoker

Primary outcome: Rate of Product Use

Time frame: IQOS users: 3-18 months IQOS use time. Mean (Standard Deviation). Unit: percentage

Measure	IQOS Users: 3 Months IQOS Use n = 70	IQOS Users: 6 Months IQOS Use n = 241	IQOS Users: 9 Months IQOS Use n = 419	IQOS Users: 12 Months IQOS Use n = 310	IQOS Users: 15 Months IQOS Use n = 158	IQOS Users: 18 Months IQOS Use n = 84
% CC	17.5 (29.0)	17.0 (27.54)	19.6 (31.18)	18.2 (30.34)	21.7 (34.23)	19.2 (33.51)
%OTP	7.2 (21.42)	9.3 (22.84)	9.5 (23.33)	9.8 (24.89)	2.3 (6.33)	2.5 (5.84)
%IQOS	75.3 (35.53)	73.7 (33.62)	70.9 (36.53)	72.0 (36.83)	68.5 (38.81)	68.9 (37.80)

Population analysed: IQOS users: 3-18 months IQOS use time

Primary outcome: Tobacco and Nicotine-containing Products Cessation

Time frame: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up. Count of participants. Unit: Participants

Measure	IQOS Users n = 599	CC Smokers n = 525
Value	5	15

Population analysed: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up

Adverse events

Time frame: 15 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 1,124 (0%)	0 of 1,124 (0%)	0 of 1,124

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kunihiko Uwatoko, MD principal investigator

Uwatoko Clinic

Pierpaolo Magnani study chair

Philip Morris Products S.A.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking and Tobacco Product, run by Philip Morris Products S.A. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Product Consumption (time frame: CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03020667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.