Puff Topogaphy

This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid. The subject used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two weeks, the subjects were confined to the clinical for one day. They were required to not use any  e-cigarettes for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit.  If the level, was too high, the visit was re-scheduled. Subjects were instructed to take 10 puffs on the e-cigarette. Puff topography was measured using the same device for all subjects. 

A  Study Reference domain, DI, was used to identify the device used to measure puff topography.  The provide a consistent sponsor-defined variable (SPDEVID) for linking data. Device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one device was used for all subjects in the study. 

The sponsor submitted the EX domain to represent the usage of the e-cigarettes. For each subject, the usage for the two weeks are represented, and then the specified usage during the in-clinic visit are shown.    

   

The FAEX domain was used to represent the puff topography associated with the in -clinic visit.  A puff -by puff analysis was performed. Additionally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session.