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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086707
Recruitment Status : Completed
First Posted : March 22, 2017
Results First Posted : October 23, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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.


Condition or disease Intervention/treatment Phase
Smokers Never Smokers Other: Cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 21, 2017
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : September 29, 2017

Arm Intervention/treatment
Active Comparator: Cigarette smokers

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.

Other: Cigarette
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.

No Intervention: Never smokers

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male subjects will be enrolled.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086707


Locations
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United States, New Jersey
Inflamax Research - Neptune
Neptune, New Jersey, United States, 07753
Inflamax Research - Newark
Newark, New Jersey, United States, 07105
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Frank Lee, MD Inflamax Research - Neptune
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] May 22, 2017
Statistical Analysis Plan  [PDF] February 24, 2017

Publications:
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03086707    
Other Study ID Numbers: P1-CMS-01-US
First Posted: March 22, 2017    Key Record Dates
Results First Posted: October 23, 2020
Last Update Posted: November 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
nasal mucociliary clearance
saccharine transit time