Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure
Status: | Active, not recruiting |
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Conditions: | Smoking Cessation |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 25 - 45 |
Updated: | 9/16/2017 |
Start Date: | January 21, 2017 |
End Date: | October 20, 2017 |
A 2-arm, Open Label, Prefatory Study to Explore Changes in Nasal Mucociliary Clearance Between Smokers and Never Smokers 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 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.
obtained for saccharin transit time (STT) test over the course of 12 hours following a single
cigarette use in 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.
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 ≤40 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.
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