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

23. oktober 2020 oppdatert av: Philip Morris Products S.A.

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

14

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • Neptune, New Jersey, Forente stater, 07753
        • Inflamax Research - Neptune
      • Newark, New Jersey, Forente stater, 07105
        • Inflamax Research - Newark

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år til 45 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Annen: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Saccharin Transit Time at t0, Start of Product Use
Tidsramme: 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.
Baseline
Saccharin Transit Time 4 Hours After Product Use
Tidsramme: 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.
Measured at 4 hours after product use.
Saccharin Transit Time 8 Hours After Product Use
Tidsramme: 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.
Measured at 8 hours after product use.
Saccharin Transit Time 12 Hours After Product Use
Tidsramme: 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.
Measured at 12 hours after product use.
Concentration of Plasma Nicotine at t0, Start of Product Use
Tidsramme: Baseline
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Baseline
Concentration of Plasma Nicotine 4 Hours After Product Use
Tidsramme: Measured at 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
Tidsramme: Measured at 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
Tidsramme: Measured at 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ribonucleic Acid Quantity (Right Nostril)
Tidsramme: 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
Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quantity (Left Nostril)
Tidsramme: 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
Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Right Nostril)
Tidsramme: 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.
Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Left Nostril)
Tidsramme: 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.
Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Philip Morris Products S.A.

Etterforskere

  • Hovedetterforsker: Frank Lee, MD, Inflamax Research - Neptune

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. januar 2017

Primær fullføring (Faktiske)

14. august 2017

Studiet fullført (Faktiske)

29. september 2017

Datoer for studieregistrering

Først innsendt

16. mars 2017

Først innsendt som oppfylte QC-kriteriene

21. mars 2017

Først lagt ut (Faktiske)

22. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • P1-CMS-01-US

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No individual participant data will be made available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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