NCT03086707

Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure

A Two-arm, Open Label, Prefatory Study to Explore Changes in Nasal Mucociliary Clearance Between Smokers and Never Smokers and to Standardize Nasal Scraping Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: Male
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study intends to evaluate the nasal mucociliary clearance (NMC) by determining the value obtained for saccharin transit time (STT) test over the course of 12 hours following a single cigarette use in adult smokers, to compare it relative to never smokers, and to examine the relationship between plasma nicotine levels and STT value in smokers and never smokers. Safety will also be monitored during the study. The planned maximum study duration for a single study participant from Screening through completion of study will be 33 days.

Conditions

• Smokers
• Never Smokers

Interventions

Type	Name	Description
OTHER	Cigarette	After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette.

Timeline

• Start date: 2017-01-21
• Primary completion: 2017-08-14
• Completion: 2017-09-29
• First posted: 2017-03-22
• Last updated: 2020-11-20
• Results posted: 2020-10-23

Locations

2 sites across 1 country: United States