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

Not Applicable

Completed

• Conditions: Smoking; Tobacco Use; Tobacco Smoking
• Interventions: Other: THS Blade device; Other: THS Induction Mono device; Other: THS Induction Mid device; Other: CIG

• Registration Number: NCT05599451
• Lead Sponsor: Philip Morris Products S.A.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2022-11-16
• Primary Completion: 2023-02-06
• Status Verified: 2023-05
• Study Completion: 2023-05-15
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THS Blade device	THS Blade device	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.
THS Induction Mono device	THS Induction Mono device	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.
THS Induction Mid device	THS Induction Mid device	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.
Cigarette	CIG	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.)

Primary Outcome Measures

Name	Time	Method
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	5 days	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.
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)	5 days	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.
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)	5 days	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.
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)	5 days	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.
Levels of Carboxyhemoglobin (COHb)	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 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.

Trial Locations

Locations (1)

Celerion; 🇬🇧 Belfast, United Kingdom