SmokingNCT02503254

Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.

A study testing CHTP 1.0 and Conventional Cigarette (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.

Official record

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Trial summary

The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to… Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: CHTP 1.0 and Conventional Cigarette (CC)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 sitePoland
Study dates: Jul 2015to Mar 2016
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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is aged ≥ 21 years.
Subject is Caucasian.
Subject is healthy, as judged by the Investigator.
Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
Subject has smoked at least for the last 3 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).
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.
Kajetany, 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 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.

Conditions: Smoking
Being tested: CHTP 1.0, Conventional Cigarette (CC)
Keywords: Smoking, Modified risk tobacco product, Conventional cigarette, Reduced exposure, Confinement, 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 1.0Other
CHTP 1.0 ad libitum 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 NCT02503254
Study group	Role	What they receive
CHTP 1.0	Experimental	Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement Receives: Other: CHTP 1.0
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 on 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 on 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 on 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 2015Mar 2016

First posted20 Jul 2015 (estimated)
Study startJul 2015
Primary completionSep 2015
Study completionMar 2016

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: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02503254
Sponsor's protocol ID: P2R-REXC-06-EU
Other IDs: P2R-REXC-06-EU
Status last verified: Jan 2023
First submitted: 17 Jul 2015
Last updated: 30 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Tran CT, Bosilkovska M, de La Bourdonnaye G, Blanc N, Haziza C. Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial. Sci Rep. 2020 Nov 5;10(1):19227. doi: 10.1038/s41598-020-76222-y.
PubMed 33154508

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 30 Jan 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 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.
ClinicalTrials.gov ID: NCT02503254
Acronym / sponsor ID: P2R-REXC-06-EU
Conditions: Smoking
Keywords: Smoking, Modified risk tobacco product, Conventional cigarette, Reduced exposure, Confinement, Carbon Heated Tobacco Product
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Sep 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 20 Jul 2015 (estimated)
Results: Posted 10 Mar 2017

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 1.0	Experimental	Other: CHTP 1.0Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) 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: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is aged ≥ 21 years.
Subject is Caucasian.
Subject is healthy, as judged by the Investigator.
Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
Subject has smoked at least for the last 3 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 1.0CHTP 1.0 ad libitum for 5 days in confinement	Other	CHTP 1.0
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 on 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 on 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 on 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 10 Mar 2017, 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 1.0	41	41
Conventional Cigarette (CC)	39	39

Primary outcome: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

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

Measure	CHTP 1.0 n = 41	Conventional Cigarette (CC) n = 39
Value	327.08 (282.39 to 378.84)	1903.61 (1637.48 to 2212.99)

CHTP 1.0 vs Conventional Cigarette (CC): Geometric LS Mean Reduction: 82.82 (95% CI 78.79 to 86.09), p <.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 (CHTP 1.0 or CC) and had at least 1 non-safety assessment.

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

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

Measure	CHTP 1.0 n = 41	Conventional Cigarette (CC) n = 39
Value	464.27 (432.13 to 498.80)	1272.96 (1182.66 to 1370.15)

CHTP 1.0 vs Conventional Cigarette (CC): Geometric LS Mean Reduction: 63.53 (95% CI 59.55 to 67.12), 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	CHTP 1.0 n = 41	Conventional Cigarette (CC) n = 39
Value	352.39 (321.26 to 386.54)	2971.98 (2703.14 to 3267.55)

CHTP 1.0 vs Conventional Cigarette (CC): Geometric LS Mean Reduction: 88.14 (95% CI 86.46 to 89.62), p <.001, ANCOVA

Primary outcome: Levels of Carboxyhemoglobin (COHb)

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

Measure	CHTP 1.0 n = 32	Conventional Cigarette (CC) n = 26
Value	2.660 (2.316 to 3.054)	6.460 (5.531 to 7.544)

CHTP 1.0 vs Conventional Cigarette (CC): Geometric LS Mean Ratio: 58.83 (95% CI 49.30 to 66.56), p <.001, ANCOVA

Population analysed: The analysis was performed on the full analysis set (FAS) population: all randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment. However, due to sample issues such as clotting, COHb assessment results could not be generated for some of the subjects.

Adverse events

Time frame: From the informed consent form signature until the end of the safety follow-up period, up to 58 days (including a screening period of up to 42 days, a 9-day confinement period followed by a 7-day safety follow-up period (7 days after discharge of the subject or early discontinuation)).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHTP 1.0	0 of 41 (0%)	27 of 41 (65.9%)	Not reported
Conventional Cigarette (CC)	0 of 39 (0%)	14 of 39 (35.9%)	Not reported
Enrolled But Not Randomized	1 of 5 (20%)	5 of 5 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33154508Tran CT, Bosilkovska M, de La Bourdonnaye G, Blanc N, Haziza C. Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial. Sci Rep. 2020 Nov 5;10(1):19227. doi: 10.1038/s41598-020-76222-y.
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.

Katarzyna Jarus-Dziedzic, MD, PhD 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 1.0 and Conventional Cigarette (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 30 Jan 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 10 Mar 2017). 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 NCT02503254, 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 30 Jan 2023.