此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2020年10月23日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

14

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • New Jersey
      • Neptune、New Jersey、美国、07753
        • Inflamax Research - Neptune
      • Newark、New Jersey、美国、07105
        • Inflamax Research - Newark

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
其他：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.
无干预：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Saccharin Transit Time at t0, Start of Product Use
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Baseline
Concentration of Plasma Nicotine 4 Hours After Product Use
大体时间：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
大体时间：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
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Ribonucleic Acid Quantity (Right Nostril)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Philip Morris Products S.A.

调查人员

  • 首席研究员：Frank Lee, MD、Inflamax Research - Neptune

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月21日

初级完成 (实际的)

2017年8月14日

研究完成 (实际的)

2017年9月29日

研究注册日期

首次提交

2017年3月16日

首先提交符合 QC 标准的

2017年3月21日

首次发布 (实际的)

2017年3月22日

研究记录更新

最后更新发布 (实际的)

2020年11月20日

上次提交的符合 QC 标准的更新

2020年10月23日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • P1-CMS-01-US

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

No individual participant data will be made available.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅