Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure
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.
Обзор исследования
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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New Jersey
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Neptune, New Jersey, Соединенные Штаты, 07753
- Inflamax Research - Neptune
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Newark, New Jersey, Соединенные Штаты, 07105
- Inflamax Research - Newark
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: 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. |
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.
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Без вмешательства: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Saccharin Transit Time at t0, Start of Product Use
Временное ограничение: Baseline
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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
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Saccharin Transit Time 4 Hours After Product Use
Временное ограничение: Measured at 4 hours after product use.
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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.
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Saccharin Transit Time 8 Hours After Product Use
Временное ограничение: Measured at 8 hours after product use.
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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.
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Saccharin Transit Time 12 Hours After Product Use
Временное ограничение: Measured at 12 hours after product use.
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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.
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Concentration of Plasma Nicotine at t0, Start of Product Use
Временное ограничение: Baseline
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Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
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Baseline
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Concentration of Plasma Nicotine 4 Hours After Product Use
Временное ограничение: Measured at 4 hours after product use.
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Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
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Measured at 4 hours after product use.
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Concentration of Plasma Nicotine 8 Hours After Product Use
Временное ограничение: Measured at 8 hours after product use.
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Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
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Measured at 8 hours after product use.
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Concentration of Plasma Nicotine 12 Hours After Product Use
Временное ограничение: Measured at 12 hours after product use.
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The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
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Measured at 12 hours after product use.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Ribonucleic Acid Quantity (Right Nostril)
Временное ограничение: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods
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Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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Ribonucleic Acid Quantity (Left Nostril)
Временное ограничение: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods
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Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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Ribonucleic Acid Quality (Right Nostril)
Временное ограничение: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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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.
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Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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Ribonucleic Acid Quality (Left Nostril)
Временное ограничение: 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.
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Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Frank Lee, MD, Inflamax Research - Neptune
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- P1-CMS-01-US
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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