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

Philip Morris

Status: Completed

Conditions: Smokers; Never Smokers

Treatments: Other: Cigarette

Study type: Interventional

Funder types: Industry

Identifiers

NCT03086707

P1-CMS-01-US

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Cigarette smokers

Active Comparator group

Description:

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.

Treatment:

Other: Cigarette

Never smokers

No Intervention group

Description:

Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years. Subjects will not be allowed to smoke until discharge at Visit 3.