Reduced Exposure to HPHC in Smokers Switching From Cigarettes to Different Versions of THS

May 25, 2023 updated by: Philip Morris Products S.A.

A Randomized, Controlled, Open-label, 4 Parallel Arms Study to Demonstrate Reductions in Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) of Cigarette (CIG) Smoke in Healthy Smokers Switching to Different Versions of Tobacco Heating System (THS) Compared to Continuing CIG Smoking, for 5 Days in Confinement

This is a randomized, controlled, open-label, 4 parallel arm study with a stratified randomization by sex (a quota for each sex [females and males] of at least 40% overall).

This study aims to demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected Harmful and Potentially Harmful Constituents (HPHC) in smokers switching from cigarettes (CIG) to each of the Tobacco Heating System (THS) variants with different heating technology (Blade device, Induction Mono device, or Induction Mid device, respectively), compared with smokers who continue to smoke CIG. A reduction of exposure to HPHC is expected in CIG smokers when switching completely to THS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The exposure period in confinement will provide information on exposure reductions achievable in a well-controlled environment with full control on daily THS stick consumption and compared to CIG smoking.

The primary hypothesis tested in this study is that BoExp considered for the primary objective will be reduced for each THS variant (Blade device, or Induction Mono device, or Induction Mid device, respectively) in subjects who adhere to switching to THS for 5 days, compared to subjects continuing CIG smoking.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subject has signed the ICF and is able to understand the information provided in the ICF.
  • Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last > 6 months in total).
  • Subject has continuously smoked on average ≥10 commercially available regular CIGs/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
  • Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).
  • Subject does not plan to quit smoking within the next three months.

Exclusion Criteria:

  • As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
  • Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
  • Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject.
  • Subject experienced within 30 days prior to screening/admission a body temperature >37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.) or the subject has a confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment)
  • As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g., start of treatment, surgery, hospitalization) during the study participation, which may interfere with the study participation and/or study results.
  • Subject has relevant history of, or current asthma condition or COPD condition, and/or clinically significant findings.
  • Subject has donated blood or received whole blood or blood products within 3 months.
  • BMI < 18.5 kg/m2 or ≥ 32.0 kg/m2.
  • Positive serology test for HIV 1/2, HBV, or HCV.
  • Subject has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
  • The subject has a positive urine drug test.
  • Subject or one of their family members is a current or former employee of the tobacco or e-cigarette industry.
  • Subject or one of their family members is an employee of the investigational site or of any other parties involved in the study.
  • Subject has participated in another clinical study within 3 months.
  • Subject has been previously screened or enrolled in this study.
  • Subject is pregnant (does not have negative pregnancy tests at screening and at admission) or is breastfeeding.
  • For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: THS Blade device
Subjects randomized to this arm will participate in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
Other: THS Blade device
Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
Other Names:
  • IQOS (THS blade device)
  • HEETS (blade heated tobacco sticks)
Active Comparator: THS Induction Mono device
Subjects randomized to this arm will participate in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
Other: THS Induction Mono device
Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
Other Names:
  • IQOS Iluma One (THS induction device)
  • TEREA (induction heated tobacco sticks)
Active Comparator: THS Induction Mid device
Subjects randomized to this arm will participate in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
Other: THS Induction Mid device
Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
Other Names:
  • TEREA (induction heated tobacco sticks)
  • IQOS Iluma (THS induction device)
Active Comparator: Cigarette

Subjects randomized to this arm will participate in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.

(Every subject will bring a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
Other: CIG
Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
Other Names:
  • Cigarette (non-mentholated)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Time Frame: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided as point estimates of reduction for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
5 days
Concentration of 2-cyanoethyl mercapturic acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
Time Frame: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided as point estimates of reduction for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
5 days
Concentration of Monohydroxybutenyl mercapturic acid (MHBMA)
Time Frame: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided as point estimates of reduction for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
5 days
Concentration of Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL)
Time Frame: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided as point estimates of reduction for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
5 days
Levels of Carboxyhemoglobin (COHb)
Time Frame: 5 days
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5. Geometric Least Squares means are provided as point estimates of reduction for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philip Morris Products S.A.

Investigators

  • Principal Investigator: Devinda Weeraratne, MD, Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2022

Primary Completion (Actual)

February 6, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1-REXC-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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