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Completed

NCT Number: NCT03086707

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

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.

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Key information

Conditions

Smokers Never Smokers

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Inflamax Research - Neptune, Neptune City, New Jersey, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cigarette

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Ribonucleic Acid Quantity (Right Nostril)

    Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

    Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods

  2. Ribonucleic Acid Quantity (Left Nostril)

    Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

    Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods

  3. Ribonucleic Acid Quality (Right Nostril)

    Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

    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.

  4. Ribonucleic Acid Quality (Left Nostril)

    Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

    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.

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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