SmokingNCT02641587

Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

A study testing CHTP 1.2 and CC in people with Smoking, run by Philip Morris Products S.A. at 1 site in Poland.

Completed

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

Trial summary

The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as… Read more about this study

Who is it for?: Ages 28 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: CHTP 1.2 and CC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 sitePoland
Study dates: Jan 2016to Jul 2017
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 28 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is aged ≥ 28 years.
Subject is Caucasian.
Subject is healthy, as judged by the Investigator.
Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
Subject has smoked at least for the last 10 years.
Subject does not plan to quit smoking in the next 6 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).
Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
Female subject is pregnant or breast feeding.
Female subject does not agree to use an acceptable method of effective contraception.

Trial locations and contacts

1 site in 1 country.

Poland1 site

BioVirtus Research Site Sp. z o.o.
Nadarzyn, 05-830

Other trials in Poland

About this study

Official title: A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2), Compared to Continuing to Use Combustible Cigarettes, for 5 Days in Confinement Followed by 85 Days in an Ambulatory Setting.

Conditions: Smoking
Being tested: CHTP 1.2, CC
Keywords: Smoking, Cigarettes, Reduced exposure, Confinement, Ambulatory, Carbon Heated Tobacco Product
Medical subject headings: Smoking

What participants receive

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

CHTP 1.2Other
Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.
CCOther
Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Study groups in NCT02641587
Study group	Role	What they receive
CHTP 1.2	Experimental	Ad libitum use of the CHTP 1.2 Receives: Other: CHTP 1.2
CC	Active comparator	Ad libitum use of subject's own preferred non-menthol brand of CC Receives: Other: CC

What is being measured

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

Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Measured: 5 days
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Measured: 5 days
Concentration of S-phenylmercapturic Acid (S-PMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
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 (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Measured: 5 days
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Concentrations measured at Day 90 in urine, adjusted for creatinine.
Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Measured: 90 days

Timeline

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

Jan 2016Jul 2017

First posted29 Dec 2015 (estimated)
Study startJan 2016
Primary completionAug 2016
Study completionJul 2017

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.
Publications (1)Papers the sponsor has linked to this study.
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: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02641587
Sponsor's protocol ID: P2R-REXA-07-EU
Status last verified: Jan 2023
First submitted: 23 Dec 2015
Last updated: 21 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Bosilkovska M, Tran CT, de La Bourdonnaye G, Taranu B, Benzimra M, Haziza C. Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product. Toxicol Lett. 2020 Sep 15;330:30-40. doi: 10.1016/j.toxlet.2020.04.013. Epub 2020 May 5.
PubMed 32380119

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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2), Compared to Continuing to Use Combustible Cigarettes, for 5 Days in Confinement Followed by 85 Days in an Ambulatory Setting.
ClinicalTrials.gov ID: NCT02641587
Acronym / sponsor ID: P2R-REXA-07-EU
Conditions: Smoking
Keywords: Smoking, Cigarettes, Reduced exposure, Confinement, Ambulatory, Carbon Heated Tobacco Product
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Jan 2016 (actual)
Primary completion: Aug 2016 (actual)
Study completion: Jul 2017 (actual)
First posted: 29 Dec 2015 (estimated)
Results: Posted 6 Mar 2019

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: 2

Arm	Type	Receives
CHTP 1.2	Experimental	Other: CHTP 1.2Ad libitum use of the CHTP 1.2
CC	Active comparator	Other: CCAd libitum use of subject's own preferred non-menthol brand of CC

Who may qualify

Ages: 28 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is aged ≥ 28 years.
Subject is Caucasian.
Subject is healthy, as judged by the Investigator.
Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
Subject has smoked at least for the last 10 years.

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).
Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
Female subject is pregnant or breast feeding.
Female 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
CHTP 1.2Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.	Other	CHTP 1.2
CCAd libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.	Other	CC

Primary outcome

Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)
Time frame: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Time frame: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Concentration of S-phenylmercapturic Acid (S-PMA)
Time frame: 5 days
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
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 (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Time frame: 90 days
Concentrations measured at Day 90 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Results and safety

Results posted to the registry on 6 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHTP 1.2	80	77
Cigarettes (CC)	40	39

Primary outcome: Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)

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

Measure	CHTP 1.2 n = 74	Cigarettes (CC) n = 34
Value	285.5 (258.0 to 315.8)	1904 (1641 to 2209)

CHTP 1.2 vs Cigarettes (CC): LS Mean Reduction: 85.01 (95% CI 82.06 to 87.47), p <0.001, Generalized linear model

Population analysed: Per Protocol (PP) population

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

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

Measure	CHTP 1.2 n = 74	Cigarettes (CC) n = 34
Value	616.8 (565.6 to 672.8)	1031 (907.9 to 1172)

CHTP 1.2 vs Cigarettes (CC): LS Mean Reduction: 40.20 (95% CI 30.25 to 48.73), p <0.001, Generalized linear model

Population analysed: Per Protocol (PP) population

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

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

Measure	CHTP 1.2 n = 74	Cigarettes (CC) n = 34
Value	386.6 (358.7 to 416.7)	2401 (2151 to 2681)

CHTP 1.2 vs Cigarettes (CC): LS Mean Reduction: 83.90 (95% CI 81.61 to 85.90), p <0.001, Generalized linear model

Population analysed: Per Protocol (PP) population

Primary outcome: Levels of Carboxyhemoglobin (COHb)

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

Measure	CHTP 1.2 n = 58	Cigarettes (CC) n = 22
Value	2.01 (1.86 to 2.16)	4.53 (4.01 to 5.11)

CHTP 1.2 vs Cigarettes (CC): LS Mean Reduction: 55.74 (95% CI 49.03 to 61.56), p <0.001, Generalized linear model

Population analysed: Per Protocol (PP) population

Adverse events

Time frame: Adverse events were collected from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period, which covered a period of between 128 to 169 days for each subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Product Test	0 of 121 (0%)	62 of 121 (51.2%)	0 of 121
CHTP 1.2 Confinement	1 of 80 (1.3%)	37 of 80 (46.3%)	0 of 80
CC Confinement	0 of 40 (0%)	12 of 40 (30%)	0 of 40
CHTP 1.2 Ambulatory	1 of 77 (1.3%)	50 of 77 (64.9%)	0 of 77
CC Ambulatory	1 of 39 (2.6%)	26 of 39 (66.7%)	0 of 39
CHTP 1.2 Safety FU	0 of 80 (0%)	1 of 80 (1.3%)	0 of 80
CC Safety FU	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40
CHTP 1.2 Post-Randomization	2 of 80 (2.5%)	64 of 80 (80%)	0 of 80
CC Post-Randomization	1 of 40 (2.5%)	31 of 40 (77.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32380119Bosilkovska M, Tran CT, de La Bourdonnaye G, Taranu B, Benzimra M, Haziza C. Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product. Toxicol Lett. 2020 Sep 15;330:30-40. doi: 10.1016/j.toxlet.2020.04.013. Epub 2020 May 5.
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.

Christelle Haziza, PhD study chair

Philip Morris Products S.A.

Monika Tomaszewska-Kiecana, MD principal investigator

BioVirtus Research Site

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

Questions about this trial

What is this clinical trial studying?

A study testing CHTP 1.2 and CC in people with Smoking, run by Philip Morris Products S.A. at 1 site in Poland.

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 6 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 21 Feb 2023. 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 Poland. 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 6 Mar 2019). 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?

Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA) (time frame: 5 days). The study lists 5 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 NCT02641587, which also lists 1 linked publication.

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 21 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.