Clinical trial NCT03086707: Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokers
Never Smokers
Keywords: nasal mucociliary clearance
saccharine transit time
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 14
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Saccharin Transit Time at t0, Start of Product Use
timeFrame: Baseline
measure: Saccharin Transit Time 4 Hours After Product Use
timeFrame: Measured at 4 hours after product use.
measure: Saccharin Transit Time 8 Hours After Product Use
timeFrame: Measured at 8 hours after product use.
measure: Saccharin Transit Time 12 Hours After Product Use
timeFrame: Measured at 12 hours after product use.
measure: Concentration of Plasma Nicotine at t0, Start of Product Use
timeFrame: Baseline
measure: Concentration of Plasma Nicotine 4 Hours After Product Use
timeFrame: Measured at 4 hours after product use.
measure: Concentration of Plasma Nicotine 8 Hours After Product Use
timeFrame: Measured at 8 hours after product use.
measure: Concentration of Plasma Nicotine 12 Hours After Product Use
timeFrame: Measured at 12 hours after product use.
Secondary outcomes:
measure: Ribonucleic Acid Quantity (Right Nostril)
timeFrame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
measure: Ribonucleic Acid Quantity (Left Nostril)
timeFrame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
measure: Ribonucleic Acid Quality (Right Nostril)
timeFrame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
measure: Ribonucleic Acid Quality (Left Nostril)
timeFrame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Inflamax Research - Neptune
state: New Jersey
city: Newark
country: United States
facility: Inflamax Research - Newark
state: New Jersey
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Inflamax Research - Neptune
name: Frank Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroeder A, Mueller O, Stocker S, Salowsky R, Leiber M, Gassmann M, Lightfoot S, Menzel W, Granzow M, Ragg T. The RIN: an RNA integrity number for assigning integrity values to RNA measurements. BMC Mol Biol. 2006 Jan 31;7:3. doi: 10.1186/1471-2199-7-3.