N/A
N=68
Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence
Nicotine · Vaping · Nicotine Vaping
Bottom Line
View on ClinicalTrials.gov: NCT05487456 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: 3-HPMA — 657.46; 726.84; 703.29; 724.06 ng/mg creatinine
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P4M3 CA35 (Other); P4M3 CM35 (Other); CIG (Other); Smoking Abstinence (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-HPMA |
657.46; 726.84; 703.29; 724.06; 154.27; 155.85 | — |
| PRIMARY 2-CyEMA |
97.17; 108.50; 98.85; 100.39; 33.47; 37.47 | — |
| PRIMARY Total NNAL |
114.66; 145.13; 116.41; 115.95; 58.27; 85.16 | — |
| PRIMARY COHb |
2.99; 2.91; 2.58; 2.71; 3.06; 3.10 | — |
Summary
To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an Electronic Nicotine Delivery System (ENDS), compared to continuing cigarette smoking for 5 days.
Eligibility Criteria
Main Inclusion Criteria:
- Subject has signed the Informed Consent Form (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).
- Subject has continuously smoked on average ≥10 commercially available mentholated or non-mentholated CIGs per day over the last 4 weeks prior to screening and admission. 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).
Main Exclusion Criteria:
- 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.)
- 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 a current asthma condition or chronic obstructive pulmonary disease (COPD) condition, and/or clinically significant spirometry findings at Screening or Baseline
- Subject has donated blood or received whole blood or blood products within 3 months prior to screening.
- BMI <18.5 kg/m2 or ≥32.0 kg/m2.
Data sourced from ClinicalTrials.gov (NCT05487456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.