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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette smokers | Active Comparator | 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. |
|
| Never smokers | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Saccharin Transit Time at t0, Start of 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. | Baseline |
| Saccharin Transit Time 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ribonucleic Acid Quantity (Right Nostril) | 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) |
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Inclusion Criteria to be met at Visit 1 and Visit 2:
Additional Inclusion Criteria to allocate subjects in one of the two groups:
Non-menthol cigarette smokers:
Never smokers:
Exclusion Criteria:
Only male subjects will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Frank Lee, MD | Inflamax Research - Neptune | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research - Neptune | Neptune City | New Jersey | 07753 | United States | ||
| Inflamax Research - Newark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16448564 | Background | Schroeder A, Mueller O, Stocker S, Salowsky R, Leiber M, Gassmann M, Lightfoot S, Menzel W, Granzow M, Ragg T. The RIN: an RNA integrity number for assigning integrity values to RNA measurements. BMC Mol Biol. 2006 Jan 31;7:3. doi: 10.1186/1471-2199-7-3. |
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No individual participant data will be made available.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Saccharin Transit Time at t0, Start of 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. | Posted | Mean | 95% Confidence Interval | minutes | Baseline |
|
Adverse events were collected over the entire study duration of up to 7 months, with individual subject participation of a maximum of 33 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood glucose decreased | Investigations | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Hoeng, PhD | Philip Morris Products S.A. | +41 (58) 242 11 11 | ClinicalTrials.PMI@pmi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2017 | Oct 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2017 | Oct 10, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Measured at 12 hours after product use. |
| Concentration of Plasma Nicotine at t0, Start of Product Use | Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method. | Baseline |
| Concentration of Plasma Nicotine 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 | 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 | The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method. | Measured at 12 hours after product use. |
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) | 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) | 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. |
| Newark |
| New Jersey |
| 07105 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| OG001 | 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. |
|
|
| Primary | Saccharin Transit Time 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. | Posted | Mean | 95% Confidence Interval | minutes | Measured at 4 hours after product use. |
|
|
|
| Primary | Saccharin Transit Time 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. | Posted | Mean | 95% Confidence Interval | minutes | Measured at 8 hours after product use. |
|
|
|
| Primary | Saccharin Transit Time 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. | Posted | Mean | 95% Confidence Interval | minutes | Measured at 12 hours after product use. |
|
|
|
| Primary | Concentration of Plasma Nicotine at t0, Start of Product Use | Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method. | Posted | Mean | 95% Confidence Interval | ng/mL | Baseline |
|
|
|
| Primary | Concentration of Plasma Nicotine 4 Hours After Product Use | Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method. | Posted | Mean | 95% Confidence Interval | ng/mL | Measured at 4 hours after product use. |
|
|
|
| Primary | Concentration of Plasma Nicotine 8 Hours After Product Use | Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method. | Posted | Mean | 95% Confidence Interval | ng/mL | Measured at 8 hours after product use. |
|
|
|
| Primary | Concentration of Plasma Nicotine 12 Hours After Product Use | The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method. | Posted | Mean | 95% Confidence Interval | ng/mL | Measured at 12 hours after product use. |
|
|
|
| Secondary | Ribonucleic Acid Quantity (Right Nostril) | Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods | 10 study participants underwent nasal scraping using either method 1 or method 2. | Posted | Mean | Standard Deviation | ng/uL | Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study. |
|
|
|
| Secondary | Ribonucleic Acid Quantity (Left Nostril) | Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods | 10 study participants underwent nasal scraping using either method 1 or method 2. | Posted | Mean | Standard Deviation | ng/uL | Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study. |
|
|
|
| Secondary | Ribonucleic Acid Quality (Right Nostril) | 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. | 10 study participants underwent nasal scraping using either method 1 or method 2. | Posted | Mean | Standard Deviation | RNA Integrity Number | Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study. |
|
|
|
| Secondary | Ribonucleic Acid Quality (Left Nostril) | 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. | 10 study participants underwent nasal scraping using either method 1 or method 2. | Posted | Mean | Standard Deviation | RNA Integrity Number | Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study. |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.
The Intellectual Property rights and research results from the present study belong to the Sponsor.