Japanese Post-Market Cohort Study

NCT03020667 | Terminated Results

• 1 other identifier: P1-PMC-01-JP
• Study Type: observational
• Target: 1,124
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Tobacco Product

Keywords

Cigarette; IQOS; Nicotine-containing product; Tobacco

Outcome Measures

Primary Outcomes (9)

• 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. * 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.

  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'.

  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

Study Arms (2)

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".

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Uwatoko Clinic

Ōzone, Nagoya, 462-0825, Japan

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Kunihiko Uwatoko, MD
• Organization: Uwatoko Clinic

uwatoko.clinic@gmail.com

+81-52-991-4602

Study Officials

• Kunihiko Uwatoko, MD

  Uwatoko Clinic

  PRINCIPAL INVESTIGATOR

• Pierpaolo Magnani

  Philip Morris Products S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: January 13, 2017
• Study Start: April 1, 2016
• Primary Completion: March 23, 2018
• Study Completion: May 30, 2018
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)