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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
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.
Inflamax Research - Neptune
Neptune City, New Jersey, United States
Inflamax Research - Newark
Newark, New Jersey, United States
Saccharin Transit Time at t0, Start of 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.
Time frame: Baseline
Saccharin Transit Time 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.
Time frame: Measured at 4 hours after product use.
Saccharin Transit Time 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.
Time frame: Measured at 8 hours after product use.
Saccharin Transit Time 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.
Time frame: Measured at 12 hours after product use.
Concentration of Plasma Nicotine at t0, Start of Product Use
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time frame: Baseline
Concentration of Plasma Nicotine 4 Hours After Product Use
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time frame: Measured at 4 hours after product use.
Concentration of Plasma Nicotine 8 Hours After Product Use
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time frame: Measured at 8 hours after product use.
Concentration of Plasma Nicotine 12 Hours After Product Use
The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time frame: Measured at 12 hours after product use.
Ribonucleic Acid Quantity (Right Nostril)
Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quantity (Left Nostril)
Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Right Nostril)
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.
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Left Nostril)
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.
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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