scholarly journals Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for a Randomized, Controlled, Multicenter Study

10.2196/11294 ◽  
2018 ◽  
Vol 7 (8) ◽  
pp. e11294 ◽  
Author(s):  
S Michael Ansari ◽  
Nicola Lama ◽  
Nicolas Blanc ◽  
Marija Bosilkovska ◽  
Andrea Donelli ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Tobacco Smoking ◽  
Heating System ◽  
Functional Changes ◽  
Randomized Controlled

scholarly journals Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for a Randomized, Controlled, Multicenter Study (Preprint)

2018 ◽  
Author(s):  
S Michael Ansari ◽  
Nicola Lama ◽  
Nicolas Blanc ◽  
Marija Bosilkovska ◽  
Andrea Donelli ◽  
...  
Keyword(s):  
Harm Reduction ◽  
Combustion Process ◽  
Heating System ◽  
Tobacco Product ◽  
Smoking History ◽  
Functional Changes ◽  
Randomized Controlled ◽  
Philip Morris ◽  
Parallel Group ◽  
Subsequent Publication

BACKGROUND Tobacco harm reduction, substituting less harmful tobacco products for combustible cigarettes, is a complementary approach for smokers who would otherwise continue to smoke. The Philip Morris International (PMI) Tobacco Heating System (THS) 2.2 is a novel tobacco product with the potential to reduce the risk of harm in smokers compared to continued smoking of combustible cigarettes. It heats tobacco electrically in a controlled manner, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from taking place and producing substantially lower levels of toxicants while providing nicotine, taste, ritual, and a sensory experience that closely parallels combustible cigarettes. Previous clinical studies have demonstrated reduced exposure to the toxicants (approaching the levels observed after quitting) for smokers who switched to THS 2.2, for three months. For adult smokers who would otherwise continue smoking combustible cigarettes, switching to THS 2.2 may represent an alternative way to reduce the risk of tobacco-related diseases. OBJECTIVE This study aimed to further substantiate the harm reduction potential of THS 2.2 by demonstrating favorable changes in a set of 8 coprimary endpoints, representative of pathomechanistic pathways (ie, inflammation, oxidative stress, lipid metabolism, respiratory function, and genotoxicity), linked to smoking-related diseases, in smokers switching from combustible cigarettes to THS 2.2. METHODS This study was a randomized, controlled, two-arm parallel group, multicenter ambulatory US study conducted in healthy adult smokers switching from combustible cigarettes to THS 2.2 compared with smokers continuing to smoke combustible cigarettes for six months. Subjects had a smoking history of at least ten years and did not intend to quit within the next six months. RESULTS Enrollment started in March 2015 and the trial was completed in September 2016. In total, 984 subjects were randomized (combustible cigarettes, n=483; THS 2.2, n=477), and 803 completed the study. The results are expected to be available in a subsequent publication in 2019. CONCLUSIONS In this paper, we describe the rationale and design for this clinical study that focused on the evaluation of THS 2.2’s potential to reduce the risk of smoking-related diseases compared with that of combustible cigarettes. This study will provide insights regarding favorable changes in biological and functional endpoints informed by effects known to be seen upon smoking cessation. CLINICALTRIAL ClinicalTrials.gov NCT02396381; http://clinicaltrials.gov/ct2/show/NCT02396381 (Archived by WebCite at http://www.webcitation.org/71PCRdagP) REGISTERED REPORT IDENTIFIER RR1-10.2196/11294

Efficacy of Andolast in Mild to Moderate Asthma: A Randomized, Controlled, Double-Blind Multicenter Study (The Andast Trial)

2015 ◽  
Vol 21 (26) ◽  
pp. 3835-3843 ◽  
Author(s):  
Mario Malerba ◽  
Massimo D`Amato ◽  
Alessandro Radaeli ◽  
Giampaolo Giacovelli ◽  
Lucio Rovati ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Double Blind ◽  
Moderate Asthma ◽  
Randomized Controlled

Non-Surgical Periodontal Therapy With Adjunctive Topical Doxycycline: A Double-Masked, Randomized, Controlled Multicenter Study. II. Microbiological Results

2005 ◽  
Vol 76 (1) ◽  
pp. 66-74 ◽  
Author(s):  
Petra Ratka-Krüger ◽  
Beate Schacher ◽  
Thomas Bürklin ◽  
Boris Böddinghaus ◽  
Rolf Holle ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Periodontal Therapy ◽  
Randomized Controlled

scholarly journals Antimicrobial treatment for ventilator-associated tracheobronchitis: a randomized controlled multicenter study

Critical Care ◽  
2008 ◽  
Vol 12 (3) ◽  
pp. R62 ◽  
Author(s):  
Saad Nseir ◽  
Raphael Favory ◽  
Elsa Jozefowicz ◽  
Franck Decamps ◽  
Florent Dewavrin ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Antimicrobial Treatment ◽  
Randomized Controlled
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