SmokingNCT01970982

Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

A study testing Tobacco Heating System (THS 2.2), Smoking abstinence (SA) and Conventional cigarette (CC) in people with Smoking, run by Philip Morris Products S.A. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional… Read more about this study

Who is it for?: Ages 23 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: Tobacco Heating System (THS 2.2), Smoking abstinence (SA) and Conventional cigarette (CC)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 166 participants
Where: 1 siteJapan
Study dates: Jul 2013to Jul 2014
Phase: Interventional
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 23 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is Japanese.
Smoking, healthy subject as judged by the Investigator.
Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
Subject has smoked for at least the last 3 consecutive years.
Subject does not plan to quit smoking in the next 3 months.

Who cannot join

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
For women: Subject is pregnant or is breast feeding.
For women: Subject does not agree to use an acceptable method of effective contraception.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku
Tokyo

Other trials in Japan

About this study

Official title: A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement

Conditions: Smoking
Being tested: Tobacco Heating System (THS 2.2), Smoking abstinence (SA), Conventional cigarette (CC)
Keywords: Candidate modified risk tobacco product, Conventional cigarette, Reduced exposure, HPHCs, Confinement
Medical subject headings: Smoking

What participants receive

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

Tobacco Heating System (THS 2.2)Other
THS 2.2 ad libitum for 5 days in confinement
Smoking abstinence (SA)Other
SA for 5 days in confinement
Conventional cigarette (CC)Other
Subject's own preferred brand of CC ad libitum for 5 days in confinement

Study groups in NCT01970982
Study group	Role	What they receive
Tobacco Heating System (THS 2.2)	Experimental	Ad libitum use of THS 2.2 for 5 days in confinement Receives: Other: Tobacco Heating System (THS 2.2)
Smoking abstinence (SA)	Sham comparator	Abstinence from smoking for 5 days in confinement Receives: Other: Smoking abstinence (SA)
Conventional cigarette (CC)	Active comparator	Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement Receives: Other: Conventional cigarette (CC)

What is being measured

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

Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares LS) means are provided as descriptive statistics.
Measured: 5 days
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics.
Measured: 5 days
Concentration of S-phenylmercapturic Acid (S-PMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics.
Measured: 5 days
Levels of Carboxyhemoglobin (COHb)
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.
Geometric Least Squares means are provided as descriptive statistics.
Measured: 5 days

Timeline

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

Jul 2013Jul 2014

First posted28 Oct 2013 (estimated)
Study startJul 2013
Primary completionDec 2013
Study completionJul 2014

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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970982
Sponsor's protocol ID: ZRHR-REXC-04-JP
Other IDs: ZRHR-REXC-04-JP
Status last verified: Mar 2020
First submitted: 18 Oct 2013
Last updated: 12 Mar 2020
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 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement
ClinicalTrials.gov ID: NCT01970982
Acronym / sponsor ID: ZRHR-REXC-04-JP
Conditions: Smoking
Keywords: Candidate modified risk tobacco product, Conventional cigarette, Reduced exposure, HPHCs, Confinement
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Dec 2013 (actual)
Study completion: Jul 2014 (actual)
First posted: 28 Oct 2013 (estimated)
Results: Posted 17 Oct 2016

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Tobacco Heating System (THS 2.2)	Experimental	Other: Tobacco Heating System (THS 2.2)Ad libitum use of THS 2.2 for 5 days in confinement
Smoking abstinence (SA)	Sham comparator	Other: Smoking abstinence (SA)Abstinence from smoking for 5 days in confinement
Conventional cigarette (CC)	Active comparator	Other: Conventional cigarette (CC)Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement

Who may qualify

Ages: 23 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is Japanese.
Smoking, healthy subject as judged by the Investigator.
Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
Subject has smoked for at least the last 3 consecutive years.
Subject does not plan to quit smoking in the next 3 months.

Key exclusion criteria (4 listed)

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
For women: Subject is pregnant or is breast feeding.
For women: Subject does not agree to use an acceptable method of effective contraception.

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

Interventions

Intervention	Type	Arms
Tobacco Heating System (THS 2.2)THS 2.2 ad libitum for 5 days in confinement	Other	Tobacco Heating System (THS 2.2)
Smoking abstinence (SA)SA for 5 days in confinement	Other	Smoking abstinence (SA)
Conventional cigarette (CC)Subject's own preferred brand of CC ad libitum for 5 days in confinement	Other	Conventional cigarette (CC)

Primary outcome

Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
Time frame: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares LS) means are provided as descriptive statistics.
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Time frame: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Concentration of S-phenylmercapturic Acid (S-PMA)
Time frame: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Levels of Carboxyhemoglobin (COHb)
Time frame: 5 days
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.

Results and safety

Results posted to the registry on 17 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tobacco Heating System (THS 2.2)	80	80
Conventional Cigarette (CC)	40	40
Smoking Abstinence (SA)	40	38

Primary outcome: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

Time frame: 5 days. Least squares mean (95% Confidence Interval). Unit: pg/mg creat

Measure	Tobacco Heating System (THS 2.2) n = 80	Conventional Cigarette (CC) n = 40	Smoking Abstinence (SA) n = 38
Value	106.25 (93.22 to 121.11)	460.15 (382.54 to 553.51)	91.73 (75.91 to 110.86)

Tobacco Heating System (THS 2.2) vs Conventional Cigarette (CC): Geometric LS Mean Ratio: 23.09 (95% CI 18.41 to 28.95), p <0.001, ANCOVA

Population analysed: The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms).

Primary outcome: Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

Time frame: 5 days. Least squares mean (95% Confidence Interval). Unit: ng/mg creat

Measure	Tobacco Heating System (THS 2.2) n = 80	Conventional Cigarette (CC) n = 40	Smoking Abstinence (SA) n = 38
Value	311.68 (286.43 to 339.16)	589.65 (523.25 to 664.47)	204.23 (180.70 to 230.82)

Tobacco Heating System (THS 2.2) vs Conventional Cigarette (CC): Geometric LS Mean Ratio: 52.86 (95% CI 45.67 to 61.17), p <0.001, ANCOVA

Primary outcome: Concentration of S-phenylmercapturic Acid (S-PMA)

Time frame: 5 days. Least squares mean (95% Confidence Interval). Unit: pg/mg creat

Measure	Tobacco Heating System (THS 2.2) n = 80	Conventional Cigarette (CC) n = 40	Smoking Abstinence (SA) n = 38
Value	142.05 (127.98 to 157.65)	905.89 (781.81 to 1049.67)	122.02 (104.92 to 141.90)

Tobacco Heating System (THS 2.2) vs Conventional Cigarette (CC): Geometric LS Mean Ratio: 15.68 (95% CI 13.09 to 18.78), p <0.001, ANCOVA

Primary outcome: Levels of Carboxyhemoglobin (COHb)

Time frame: 5 days. Least squares mean (95% Confidence Interval). Unit: % of saturation of hemoglobin

Measure	Tobacco Heating System (THS 2.2) n = 80	Conventional Cigarette (CC) n = 40	Smoking Abstinence (SA) n = 38
Value	2.41 (2.33 to 2.51)	5.13 (4.87 to 5.39)	2.37 (2.24 to 2.50)

Tobacco Heating System (THS 2.2) vs Conventional Cigarette (CC): Geometric LS Mean Ratio: 47.10 (95% CI 44.30 to 50.08), p <0.001, ANCOVA

Adverse events

Time frame: From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tobacco Heating System (THS 2.2)	0 of 80 (0%)	2 of 80 (2.5%)	Not reported
Conventional Cigarette (CC)	0 of 40 (0%)	2 of 40 (5%)	Not reported
Smoking Abstinence (SA)	0 of 40 (0%)	0 of 40 (0%)	Not reported
Enrolled But Not Randomized	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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.

Takuya Kunito, MD principal investigator

Higashi Shinjuku Clinic

Christelle Haziza, PhD 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?

A study testing Tobacco Heating System (THS 2.2), Smoking abstinence (SA) and Conventional cigarette (CC) in people with Smoking, 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 5 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: finished, as of the sponsor's last update on 12 Mar 2020. 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. Some participants in this study may receive a placebo. 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 17 Oct 2016). 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?

Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) (time frame: 5 days). The study lists 4 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 NCT01970982.

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 12 Mar 2020.