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

NCT05599451 | Completed Results

• 1 other identifier: P1-REXC-10
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This was 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 aimed 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 continued to smoke CIG.

Conditions

Smoking; Tobacco Smoking; Tobacco Use

Keywords

Exposure Response; Smoking; Tobacco Heating System; Heated Tobacco

Outcome Measures

Primary Outcomes (5)

• Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

  Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided 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)

  Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided 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)

  Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided 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)

  Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided 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)

  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 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

Study Arms (4)

THS Blade device

ACTIVE COMPARATOR

Subjects randomized to this arm participated 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

THS Induction Mono device

ACTIVE COMPARATOR

Subjects randomized to this arm participated 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

THS Induction Mid device

ACTIVE COMPARATOR

Subjects randomized to this arm participated 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

Cigarette

ACTIVE COMPARATOR

Subjects randomized to this arm participated 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 brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)

Other: CIG

Interventions

THS Blade device OTHER

Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use

Also known as: IQOS (THS blade device), HEETS (blade heated tobacco sticks)

THS Blade device

THS Induction Mono device OTHER

Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).

Also known as: IQOS Iluma One (THS induction device), TEREA (induction heated tobacco sticks)

THS Induction Mono device

THS Induction Mid device OTHER

Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).

Also known as: IQOS Iluma (THS induction device), TEREA (induction heated tobacco sticks)

THS Induction Mid device

CIG OTHER

Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)

Also known as: Cigarette (non-mentholated)

Cigarette

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Celerion

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Smoking; Tobacco Smoking; Tobacco Use

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Christelle Haziza, Global Head Clinical Research and Operations
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41582421111

Study Officials

• Devinda Weeraratne, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, open-label, 4 parallel arms study

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 4, 2022
• Primary Completion: February 4, 2023
• Study Completion: May 15, 2023
• Last Updated: September 20, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)