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

NCT03086707 | Completed Results

• 1 other identifier: P1-CMS-01-US
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Smokers; Never Smokers

Keywords

nasal mucociliary clearance; saccharine transit time

Outcome Measures

Primary Outcomes (8)

• Saccharin Transit Time at t0, Start of 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.

  Baseline

• Saccharin Transit Time 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.

  Measured at 4 hours after product use.

• Saccharin Transit Time 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.

  Measured at 8 hours after product use.

• Saccharin Transit Time 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.

  Measured at 12 hours after product use.

• Concentration of Plasma Nicotine at t0, Start of Product Use

  Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.

  Baseline

• Concentration of Plasma Nicotine 4 Hours After Product Use

  Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.

  Measured at 4 hours after product use.

• Concentration of Plasma Nicotine 8 Hours After Product Use

  Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.

  Measured at 8 hours after product use.

• Concentration of Plasma Nicotine 12 Hours After Product Use

  The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.

  Measured at 12 hours after product use.

Secondary Outcomes (4)

• Ribonucleic Acid Quantity (Right Nostril)

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

• Ribonucleic Acid Quantity (Left Nostril)

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

• Ribonucleic Acid Quality (Right Nostril)

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

• Ribonucleic Acid Quality (Left Nostril)

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

Study Arms (2)

Cigarette smokers

ACTIVE COMPARATOR

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

Never smokers

NO INTERVENTION

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.

Interventions

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.

Cigarette smokers

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Only male subjects will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (2)

Inflamax Research - Neptune

Neptune City, New Jersey, 07753, United States

Location

Inflamax Research - Newark

Newark, New Jersey, 07105, United States

Location

Related Publications (1)

• 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.

  PMID: 16448564 BACKGROUND

MeSH Terms

Interventions

Tobacco Products

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Julia Hoeng, PhD
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 (58) 242 11 11

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

• Frank Lee, MD

  Inflamax Research - Neptune

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: January 21, 2017
• Primary Completion: August 14, 2017
• Study Completion: September 29, 2017
• Last Updated: November 20, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)