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

23. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Jersey
      • Neptune, New Jersey, Forenede Stater, 07753
        • Inflamax Research - Neptune
      • Newark, New Jersey, Forenede Stater, 07105
        • Inflamax Research - Newark

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Andet: 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 indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Philip Morris Products S.A.

Efterforskere

  • Ledende efterforsker: Frank Lee, MD, Inflamax Research - Neptune

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. januar 2017

Primær færdiggørelse (Faktiske)

14. august 2017

Studieafslutning (Faktiske)

29. september 2017

Datoer for studieregistrering

Først indsendt

16. marts 2017

Først indsendt, der opfyldte QC-kriterier

21. marts 2017

Først opslået (Faktiske)

22. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • P1-CMS-01-US

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No individual participant data will be made available.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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