N/A
N=984
Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02396381 ↗Enrolled (actual)
984
Serious AEs
1.3%
Results posted
Aug 2019
Primary outcome: Primary: Levels of High Density Lipoprotein C (HDL-C). — 54.1; 50.9; 56.3; 52.8 mg/dL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- THS 2.2 (Other); CC (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levels of High Density Lipoprotein C (HDL-C). |
54.1; 50.9; 56.3; 52.8 | <0.001 sig |
| PRIMARY Levels of White Blood Cells (WBC). |
6.98; 7.48; 7.41; 8.71 | 0.001 sig |
| PRIMARY Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1). |
95.4; 93.4; 93.7; 94.3 | 0.008 sig |
| PRIMARY Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). |
252; 266; 270; 273 | 0.030 sig |
| PRIMARY Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). |
496; 523; 532; 626 | 0.193 |
| PRIMARY Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). |
321; 351; 347; 335 | 0.018 sig |
| PRIMARY Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). |
144; 282; 286; 342 | <0.001 sig |
| PRIMARY Percent Change From Baseline of Carboxyhemoglobin (COHb) |
2.84; 4.38; 4.23; 5.59 | <0.001 sig |
Summary
The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period.
To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.
Eligibility Criteria
Inclusion Criteria
- Current healthy smoker as judged by the Principal Investigator(s) or designee(s)
- Minimum age: 30 years old
- Have smoked for the last 10 years
- Have smoked more than 10 non menthol CC/day on average (no brand restriction) over the past year
Exclusion Criteria
- Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
- Subject who has (FEV1/FVC) 200 mL from pre- to post-bronchodilator values)
- Subject who took or is taking concomitant medication which may have an impact on the "smoker's heath profile"
- Female subject is pregnant or breast feeding.
- Female subject who does not agree to use an acceptable method of effective contraception.
Data sourced from ClinicalTrials.gov (NCT02396381). 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.