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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.

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 22, 2017
Results First Submitted Date  ICMJE October 21, 2019
Results First Posted Date  ICMJE October 23, 2020
Last Update Posted Date November 20, 2020
Actual Study Start Date  ICMJE January 21, 2017
Actual Primary Completion Date August 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • 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.
  • Saccharin transit time 4 hours after product use [ Time Frame: up to 4 hours ]
    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.
  • Saccharin transit time 8 hours after product use [ Time Frame: up to 8 hours ]
    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.
  • Saccharin transit time 12 hours after product use [ Time Frame: up to 12 hours ]
    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.
  • 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.
  • Concentration of plasma nicotine 4 hours after product use [ Time Frame: Baseline + 4 hours ]
    Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
  • Concentration of plasma nicotine 8 hours after product use [ Time Frame: Baseline + 8 hours ]
    Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
  • Concentration of plasma nicotine 12 hours after product use [ Time Frame: Baseline + 12 hours ]
    The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Smokers
  • Never Smokers
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: 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.

Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 29, 2017
Actual Primary Completion Date August 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Only male subjects will be enrolled.
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03086707
Other Study ID Numbers  ICMJE P1-CMS-01-US
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be made available.
Current Responsible Party Philip Morris Products S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Philip Morris Products S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Frank Lee, MD Inflamax Research - Neptune
PRS Account Philip Morris Products S.A.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP