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

Not Applicable

Completed

Conditions: Smokers
Never Smokers

Interventions: Other: Cigarette

Registration Number: NCT03086707

Lead Sponsor: Philip Morris Products S.A.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

As per the Investigator's judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
Inability to taste sweet within 60 minutes in the STT test.
Any condition the Principal Investigator or designee has cause to believe would interfere with the procedures for upper or lower airway function. This could include, but is not limited to, nasal/septum deviations, or nasal polyps or nasal allergies.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cigarette smokers	Cigarette	Subjects who have smoked at least 20 cigarettes per day for at least the past 5 years. Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period.

Primary Outcome Measures

Name	Time	Method
Saccharin Transit Time at t0, Start of Product Use	Baseline	Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Concentration of Plasma Nicotine at t0, Start of Product Use	Baseline	Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Saccharin Transit Time 12 Hours After Product Use	Measured at 12 hours after product use.	Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Concentration of Plasma Nicotine 12 Hours After Product Use	Measured at 12 hours after product use.	The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Saccharin Transit Time 8 Hours After Product Use	Measured at 8 hours after product use.	Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Concentration of Plasma Nicotine 8 Hours After Product Use	Measured at 8 hours after product use.	Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Saccharin Transit Time 4 Hours After Product Use	Measured at 4 hours after product use.	Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Concentration of Plasma Nicotine 4 Hours After Product Use	Measured at 4 hours after product use.	Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.

Secondary Outcome Measures

Name	Time	Method
Ribonucleic Acid Quantity (Right Nostril)	Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.	Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods
Ribonucleic Acid Quality (Left Nostril)	Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.	Ribonucleic Acid quality assessed using the RNA integrity number: measured in the left nostril (Qiazol buffer) using two nasal scraping methods. RNA integrity Number is an algorithm for assessing RNA integrity and based on a numbering system from 1 to 10, with 1 being the most degraded profile and 10 being the most intact.
Ribonucleic Acid Quantity (Left Nostril)	Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.	Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods
Ribonucleic Acid Quality (Right Nostril)	Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.	Ribonucleic Acid quality assessed using the RNA integrity number: measured in the right nostril (RNA protect buffer) using two nasal scraping methods. RNA integrity Number is an algorithm for assessing RNA integrity and based on a numbering system from 1 to 10, with 1 being the most degraded profile and 10 being the most intact.