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

NCT ID: NCT03086707

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-21
• Study Completion Date: 2017-09-29

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cigarette

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle Haziza, PhD

Role: STUDY_CHAIR

Philip Morris Products S.A.

Frank Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Inflamax Research - Neptune

Locations

Inflamax Research - Neptune

Neptune City, New Jersey, United States

Inflamax Research - Newark

Newark, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16448564 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P1-CMS-01-US

Identifier Type: -

Identifier Source: org_study_id