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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086707
Recruitment Status : Completed
First Posted : March 22, 2017
Results First Posted : October 23, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Smokers
Never Smokers
Intervention Other: Cigarette
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Cigarette Smokers Never Smokers Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
33.9  (7.20) 32.1  (4.30) 33.0  (5.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
7
 100.0%
14
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Hispanic or Latino
0
   0.0%
4
  57.1%
4
  28.6%
Not Hispanic or Latino
7
 100.0%
3
  42.9%
10
  71.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  14.3%
1
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  57.1%
3
  42.9%
7
  50.0%
White
3
  42.9%
3
  42.9%
6
  42.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 7 participants 7 participants 14 participants
73.3  (7.18) 85.9  (11.60) 79.6  (11.35)
1.Primary Outcome
Title Saccharin Transit Time at t0, Start of Product Use
Hide Description

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.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: minutes
8.4
(4.81 to 11.89)
10.1
(4.05 to 16.21)
2.Primary Outcome
Title Saccharin Transit Time 4 Hours After Product Use
Hide Description

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.

Time Frame Measured at 4 hours after product use.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: minutes
8.0
(5.83 to 10.12)
7.1
(1.98 to 12.28)
3.Primary Outcome
Title Saccharin Transit Time 8 Hours After Product Use
Hide Description

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.

Time Frame Measured at 8 hours after product use.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: minutes
9.9
(3.25 to 16.57)
10.1
(3.03 to 17.11)
4.Primary Outcome
Title Saccharin Transit Time 12 Hours After Product Use
Hide Description

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.

Time Frame Measured at 12 hours after product use.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: minutes
8.6
(5.34 to 11.78)
9.0
(2.61 to 15.47)
5.Primary Outcome
Title Concentration of Plasma Nicotine at t0, Start of Product Use
Hide Description Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
18.8
(13.83 to 23.80)
0.0
(0.00 to 0.00)
6.Primary Outcome
Title Concentration of Plasma Nicotine 4 Hours After Product Use
Hide Description Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time Frame Measured at 4 hours after product use.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
4.6
(1.25 to 7.90)
0.2 [1] 
(NA to NA)
[1]
All subjects in the never smoker group presented a plasma value below the Lower Limit of Quantification at the study timepoints.
7.Primary Outcome
Title Concentration of Plasma Nicotine 8 Hours After Product Use
Hide Description Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time Frame Measured at 8 hours after product use.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
2.8
(0.35 to 5.26)
0.2 [1] 
(NA to NA)
[1]
All subjects in the never smoker group presented a plasma value below the Lower Limit of Quantification at the study timepoints.
8.Primary Outcome
Title Concentration of Plasma Nicotine 12 Hours After Product Use
Hide Description The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Time Frame Measured at 12 hours after product use.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
3.9
(-2.24 to 9.96)
0.2 [1] 
(NA to NA)
[1]
All subjects in the never smoker group presented a plasma value below the Lower Limit of Quantification at the study timepoints.
9.Secondary Outcome
Title Ribonucleic Acid Quantity (Right Nostril)
Hide Description Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods
Time Frame Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Hide Outcome Measure Data
Hide Analysis Population Description
10 study participants underwent nasal scraping using either method 1 or method 2.
Arm/Group Title Nasal Scraping Method 1 Nasal Scraping Method 2
Hide Arm/Group Description:
Five study participants underwent nasal scraping using method 1.
Five study participants underwent nasal scraping using method 2.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: ng/uL
47.5  (23.83) 44.0  (43.77)
10.Secondary Outcome
Title Ribonucleic Acid Quantity (Left Nostril)
Hide Description Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods
Time Frame Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Hide Outcome Measure Data
Hide Analysis Population Description
10 study participants underwent nasal scraping using either method 1 or method 2.
Arm/Group Title Nasal Scraping Method 1 Nasal Scraping Method 2
Hide Arm/Group Description:
Five study participants underwent nasal scraping using method 1.
Five study participants underwent nasal scraping using method 2.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: ng/uL
46.2  (36.64) 57.9  (39.94)
11.Secondary Outcome
Title Ribonucleic Acid Quality (Right Nostril)
Hide Description 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.
Time Frame Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Hide Outcome Measure Data
Hide Analysis Population Description
10 study participants underwent nasal scraping using either method 1 or method 2.
Arm/Group Title Nasal Scraping Method 1 Nasal Scraping Method 2
Hide Arm/Group Description:
Five study participants underwent nasal scraping using method 1.
Five study participants underwent nasal scraping using method 2.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: RNA Integrity Number
8.6  (1.13) 7.1  (1.91)
12.Secondary Outcome
Title Ribonucleic Acid Quality (Left Nostril)
Hide Description 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.
Time Frame Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Hide Outcome Measure Data
Hide Analysis Population Description
10 study participants underwent nasal scraping using either method 1 or method 2.
Arm/Group Title Nasal Scraping Method 1 Nasal Scraping Method 2
Hide Arm/Group Description:
Five study participants underwent nasal scraping using method 1.
Five study participants underwent nasal scraping using method 2.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: RNA Integrity Number
2.4  (0.54) 2.3  (0.41)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cigarette Smokers Never Smokers
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cigarette Smokers Never Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Cigarette Smokers Never Smokers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cigarette Smokers Never Smokers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/7 (0.00%)    
Investigations     
Blood glucose decreased * 1  1/7 (14.29%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julia Hoeng, PhD
Organization: Philip Morris Products S.A.
Phone: +41 (58) 242 11 11
EMail: ClinicalTrials.PMI@pmi.com
Layout table for additonal information
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03086707    
Other Study ID Numbers: P1-CMS-01-US
First Submitted: March 16, 2017
First Posted: March 22, 2017
Results First Submitted: October 21, 2019
Results First Posted: October 23, 2020
Last Update Posted: November 20, 2020