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- W2980420293 abstract "SESSION TITLE: Monday Electronic Posters 5 SESSION TYPE: Original Inv Poster Discussion PRESENTED ON: 10/21/2019 02:30 PM - 03:15 PM PURPOSE: The Tobacco Heating System (THS) 2.2 is a novel product that electrically heats tobacco at temperatures significantly lower (< 350°C) than those generated when burning cigarettes (CC), producing substantially lower levels of harmful and potentially harmful constituents, with a mean decrease of 90%. A randomized, two-arm parallel group, multicenter exposure study conducted in the U.S. (NCT02396381) demonstrated statistically significant changes in five of eight biomarkers of effect (BoEff) at six months among adults switching to THS compared with those who continued smoking, meeting the primary study objective, with all BoEff moving in the direction of smoking cessation (SC). The study was extended by an additional six months (NCT02649556), and these favorable changes were maintained over 12 months. METHODS: This analysis was designed to explore the effect of switching to THS (n=17) compared with continued smoking (n=28) in a subgroup of subjects from the two aforementioned exposure studies with baseline spirometry indicating mild to moderate chronic obstructive pulmonary disease (COPD) according to GOLD 2018 criteria. Results from a subset of subjects (n=18) with mild COPD from a one-year continuous smoking abstinence study (NCT02432729) were used as a reference. The analysis was also conducted on a broadened subgroup including subjects with obstruction defined by forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≤ 0.75, based on the Lung Health Study’s review1 of mild to moderate COPD that defined obstruction with the precedent American Thoracic Society guidelines. The main respiratory and cardiovascular endpoints were white blood cell count (WBC), soluble intercellular adhesion molecule 1 (sICAM-1), and 8-epi-prostaglandin F2α (8-epi-PGF2α). RESULTS: After 12 months of follow up, favorable shifts in the direction of changes observed in SC were observed for most of the BoEff in COPD subjects following predominant (>=70%) THS use. The magnitude of these shifts was more pronounced than those observed in the general population of exposure studies, where a majority of healthy subjects were enrolled, with a THS-CC difference of 72 mL in FEV1 among COPD subjects and a reduction for THS of 1.95 GI/L in WBC, 6.8% in sICAM-1, and 28% in 8-epi-PGF2α compared with CC. CONCLUSIONS: he results of this preliminary analysis are coherent with the main study findings, with marked changes observed among subjects with COPD. CLINICAL IMPLICATIONS: The results of this preliminary analysis suggest reduced harm potential for THS compared with smoking in mild to moderate COPD subjects. DISCLOSURES: Employee relationship with Philip Morris Products S.A. Please note: >$100000 Added 01/29/2019 by S. Michael Ansari, source=Web Response, value=Salary No relevant relationships by Ashraf Elamin, source=Web Response Employee relationship with Philip Morris Products SA Please note: >$100000 Added 03/15/2019 by Loyse Felber Medlin, source=Web Response, value=Salary No relevant relationships by Christelle Haziza, source=Web Response My spouse/partner as a Employee relationship with Medtronic Please note: >$100000 Added 03/15/2019 by Nicola Lama, source=Web Response, value=Salary Employee relationship with PMP SA Please note: >$100000 Added 03/15/2019 by Nicola Lama, source=Web Response, value=Salary My spouse/partner as a Stock holder relationship with Medtronic Please note: $20001 - $100000 Added 03/15/2019 by Nicola Lama, source=Web Response, value=stocks No relevant relationships by Francesco Sergio, source=Web Response" @default.
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- W2980420293 date "2019-10-01" @default.
- W2980420293 modified "2023-09-27" @default.
- W2980420293 title "TOBACCO HEATING SYSTEM 2.2 IN MILD TO MODERATE COPD SUBJECTS: AN EXPLORATORY ANALYSIS" @default.
- W2980420293 doi "https://doi.org/10.1016/j.chest.2019.08.485" @default.
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