N/A
N=14
Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure
Smokers · Never Smokers
Bottom Line
View on ClinicalTrials.gov: NCT03086707 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Saccharin Transit Time at t0, Start of Product Use — 8.4; 10.1 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cigarette (Other)
- Age
- Adult · 25+ yrs
- Sex
- Male
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Saccharin Transit Time at t0, Start of Product Use |
8.4; 10.1 | — |
| PRIMARY Saccharin Transit Time 4 Hours After Product Use |
8.0; 7.1 | — |
| PRIMARY Saccharin Transit Time 8 Hours After Product Use |
9.9; 10.1 | — |
| PRIMARY Saccharin Transit Time 12 Hours After Product Use |
8.6; 9.0 | — |
| PRIMARY Concentration of Plasma Nicotine at t0, Start of Product Use |
18.8; 0.0 | — |
| PRIMARY Concentration of Plasma Nicotine 4 Hours After Product Use |
4.6; 0.2 | — |
| PRIMARY Concentration of Plasma Nicotine 8 Hours After Product Use |
2.8; 0.2 | — |
| PRIMARY Concentration of Plasma Nicotine 12 Hours After Product Use |
3.9; 0.2 | — |
| SECONDARY Ribonucleic Acid Quantity (Right Nostril) |
47.5; 44.0 | — |
| SECONDARY Ribonucleic Acid Quantity (Left Nostril) |
46.2; 57.9 | — |
| SECONDARY Ribonucleic Acid Quality (Right Nostril) |
8.6; 7.1 | — |
| SECONDARY Ribonucleic Acid Quality (Left Nostril) |
2.4; 2.3 | — |
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.
Eligibility Criteria
Inclusion Criteria to be met at Visit 1 and Visit 2:
- Male smokers aged ≥25 to ≤45 years old.
- Male never smokers aged ≥25 to ≤45 years old.
- Subject's BMI is comprised between 18.0 kg/m2 to 32.0 kg/m2, inclusive.
- Subject is healthy, as judged by the Investigator.
Additional Inclusion Criteria to allocate subjects in one of the two groups:
- Non-menthol cigarette smokers:
- A positive urine cotinine test (≥200 ng/mL).
- Smoked at least 20 cigarettes per day for at least the past 5 years.
- eCO levels >10 parts per million (ppm).
- No plans to quit smoking in the next 3 months.
- Never smokers:
- Subject who has smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.
- A negative urine cotinine test (<200 ng/mL).
- eCO levels ≤ 5 ppm.
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.
Data sourced from ClinicalTrials.gov (NCT03086707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.