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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philip Morris Products S.A.
- Enrollment
- 14
- Locations
- 4
- Primary Endpoint
- Concentration of Plasma Nicotine 12 Hours After Product Use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Concentration of Plasma Nicotine 12 Hours After Product Use
Time Frame: Measured at 12 hours after product use.
The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Concentration of Plasma Nicotine at t0, Start of Product Use
Time Frame: Baseline
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Saccharin Transit Time at t0, Start of Product Use
Time Frame: 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.
Saccharin Transit Time 12 Hours After Product Use
Time Frame: 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.
Saccharin Transit Time 8 Hours After Product Use
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Measured at 4 hours after product use.
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Secondary Outcomes
- Ribonucleic Acid Quantity (Right Nostril)(Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.)
- Ribonucleic Acid Quality (Left Nostril)(Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.)
- Ribonucleic Acid Quantity (Left Nostril)(Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.)
- Ribonucleic Acid Quality (Right Nostril)(Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.)