Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476405
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-20
Brief Title:
Room Air Levels of Harmful and Potentially Harmful Constituents After Heated Tobacco Product Use and Cigarettes
Sponsor:
Altria Client Services LLC
Organization:
Altria Client Services LLC
Study Overview
Official Title:
An Open-Label Study to Characterize Selected Harmful and Potentially Harmful Constituents and Aerosol Analytes From Ambient Air Following the Use of Ploom Heated Tobacco Products and Combustible Cigarettes by Adults Who Smoke
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to assess and characterize levels of selected harmful and potentially harmful constituents HPHCs and other endpoints of interest in an environmental chamber EC after ad libitum use of Ploom heated tobacco product HTP and combustible cigarettes CC in their respective group menthol and non-menthol smokers by adults who smoke AS
Detailed Description:
This is an open-label single center study to characterize selected HPHCs and other aerosol analytes from ambient air in an enclosed room following the use of Ploom HTPs and CCs by adults who smoke The airborne constituents to be investigated during this study include compounds from the established US FDA list of HPHCs compounds from the WHO priority list of toxicants constituents with relevance for air quality and product-specific markers The study will include healthy adult male and female who smoke commercially available CC with at least 24 non-menthol Group 1 cigarette smokers and 24 menthol Group 2 cigarette smokers every effort should be made to ensure no more than 60 of either gender for each group Adult subjects will be between 22 and 65 years of age at screening inclusive and will self-report at least the previous year and current non-menthol Group 1 or menthol Group 2 factory manufactured CC smoking Subjects must have a history of smoking 5 or more non-menthol Group 1 or 5 or more menthol Group 2 CCs daily for at least 12 months prior to Screening
This study is designed to assess in Group 1 the levels of selected HPHCs and other aerosol analytes in an environmental test chamber after use of the Ploom device with non-menthol tobacco sticks relative to commercially available UBCC non-menthol combustible cigarettes and in Group 2 the levels of HPHCs and other aerosol analytes in an environmental test chamber after use of the Ploom device with menthol tobacco sticks relative to commercially available UBCC menthol combustible cigarettes The room air samples for Baseline without study product use and Test with study product use will be collected following a cohort of 4 subjects staying inside the smoking chamber for 20 minutes with use or not use of study products The cohort of 4 subjects will be randomly assigned at each chamber test session CTS visit from a pool of subjects
The study will consist of 4 visits These visits include a Screening Visit Visit 1 Day -28 to Day -1 a Product Trial Visit Visit 2 Day -7 to Day -1 and 2 Chamber Test Session CTS visits Visit 3 Day 0 and Visit 4 Day 1 to Day 7 All subjects will follow this schedule
Screening Visit Visit 1
Subjects will visit the site for screening Each subject will read and sign the Informed Consent Form ICF to confirm their agreement to participate in the study Data related to demography medical history tobacco use history and physical examination will be collected In addition the Investigator will provide information on tobacco cessation and QuitAssist website at the screening and end of study or early termination visit
Product Trial Visit Visit 2
Subjects who pass the screening will be assigned to Non-menthol Group 1 or Menthol Group 2 Study Groups based on their usual brand of combustible cigarette UBCC At this visit each subject will have a 2-hour product trial to try the Ploom HTP with non-menthol Group 1 or menthol Group 2 Ploom HTS
Chamber Test Sessions CTS Visits 3 - 4
Following Product Trial each subject will return to site and 4 subjects at each visit will participant in the product use session inside an environmental chamber EC
Each of the Study Groups will be divided into 3 Subgroups with 8 subjects each At each CTS visit a cohort of 4 subjects will be randomly assigned from one of the Subgroups and completes the 2 CTS sessions per visit consisting of Baseline without study product use and Test with study product use
Check in A Subgroup of up to 8 subjects will check-in in the morning of each session day to the clinic to ensure that a cohort of 4 subjects will be available for each of the 2 CTS sessions
CTS Four subjects will enter and stay inside the environment chamber EC for 20 minutes two times one for Baseline CTS in the morning and one for Test CTS in the afternoon
1 Baseline CTS subjects will remain in a static EC for 20 minutes without using any study product
2 Test CTS subjects will remain in a static EC for 20 minutes and use one unit of the assigned study product for 10 minutes
All the 4 subjects should enter and exit the chamber at approximately the same time
Subject Selection
At each CTS Visit a subgroup of approximately 8 subjects will check in to the clinic to ensure 4 subjects will be entering the chamber for that visit Up to 2 alternate subjects will also be selected to replace anyone who failed to enter the chamber for any of the EC sessions A tool eg an excel spreadsheet will be used to randomly select up to 6 subjects from the subgroup Every effort should be made to select no more than 60 of subjects from each gender for each cohort
On each CTS day the continuous endpoints for air quality inside the EC will be monitored real-time and recorded including carbon dioxide carbon monoxide temperature relative humidity air exchange rate and total volatile organic compounds TVOC Air monitoring will be performed using sensors located inside the EC and start at a predetermined time prior to the subjects entering the chamber and end after the last Time- weighted average TWA sampling is complete These will be visually monitored during chamber sessions days but will be recorded at a time starting immediately following the cohort has entered the chamber until TWA sampling is complete
During the CTS the air samples for time-weighted-average endpoints for selected analytes inside the EC will be acquired using individual pumped samplers installed at one location inside the EC for 2 hours starting immediately within 3 minutes after subjects exit the chamber for the Baseline without study product use and Test with study product use CTSs respectively These analytes include Respirable Suspended Particles RSP 25µm Ultraviolet Particulate Matter UVPM Florescence Particulate Matter FPM Solanesol Nicotine 3-ethenylpyridine 3-EP Ammonia Formaldehyde Acetaldehyde Benzene ortho-Cresol meta- and para-Cresol Ethylbenzene Glycerol Phenol Pyridine Pyrrole Styrene Toluene ortho-Xylene meta- and para-Xylene and TVOC-derived
The total duration of the study from the first subject check-in through the last subject check-out will be approximately 6 weeks approximately 42 days
This study is designed to assess in Group 1 the levels of selected HPHCs and other aerosol analytes in an environmental test chamber after use of the Ploom device with non-menthol tobacco sticks relative to commercially available UBCC non-menthol combustible cigarettes and in Group 2 the levels of HPHCs and other aerosol analytes in an environmental test chamber after use of the Ploom device with menthol tobacco sticks relative to commercially available UBCC menthol combustible cigarettes The room air samples for Baseline without study product use and Test with study product use will be collected following a cohort of 4 subjects staying inside the smoking chamber for 20 minutes with use or not use of study products The cohort of 4 subjects will be randomly assigned at each chamber test session CTS visit from a pool of subjects
The study will consist of 4 visits These visits include a Screening Visit Visit 1 Day -28 to Day -1 a Product Trial Visit Visit 2 Day -7 to Day -1 and 2 Chamber Test Session CTS visits Visit 3 Day 0 and Visit 4 Day 1 to Day 7 All subjects will follow this schedule
Screening Visit Visit 1
Subjects will visit the site for screening Each subject will read and sign the Informed Consent Form ICF to confirm their agreement to participate in the study Data related to demography medical history tobacco use history and physical examination will be collected In addition the Investigator will provide information on tobacco cessation and QuitAssist website at the screening and end of study or early termination visit
Product Trial Visit Visit 2
Subjects who pass the screening will be assigned to Non-menthol Group 1 or Menthol Group 2 Study Groups based on their usual brand of combustible cigarette UBCC At this visit each subject will have a 2-hour product trial to try the Ploom HTP with non-menthol Group 1 or menthol Group 2 Ploom HTS
Chamber Test Sessions CTS Visits 3 - 4
Following Product Trial each subject will return to site and 4 subjects at each visit will participant in the product use session inside an environmental chamber EC
Each of the Study Groups will be divided into 3 Subgroups with 8 subjects each At each CTS visit a cohort of 4 subjects will be randomly assigned from one of the Subgroups and completes the 2 CTS sessions per visit consisting of Baseline without study product use and Test with study product use
Check in A Subgroup of up to 8 subjects will check-in in the morning of each session day to the clinic to ensure that a cohort of 4 subjects will be available for each of the 2 CTS sessions
CTS Four subjects will enter and stay inside the environment chamber EC for 20 minutes two times one for Baseline CTS in the morning and one for Test CTS in the afternoon
1 Baseline CTS subjects will remain in a static EC for 20 minutes without using any study product
2 Test CTS subjects will remain in a static EC for 20 minutes and use one unit of the assigned study product for 10 minutes
All the 4 subjects should enter and exit the chamber at approximately the same time
Subject Selection
At each CTS Visit a subgroup of approximately 8 subjects will check in to the clinic to ensure 4 subjects will be entering the chamber for that visit Up to 2 alternate subjects will also be selected to replace anyone who failed to enter the chamber for any of the EC sessions A tool eg an excel spreadsheet will be used to randomly select up to 6 subjects from the subgroup Every effort should be made to select no more than 60 of subjects from each gender for each cohort
On each CTS day the continuous endpoints for air quality inside the EC will be monitored real-time and recorded including carbon dioxide carbon monoxide temperature relative humidity air exchange rate and total volatile organic compounds TVOC Air monitoring will be performed using sensors located inside the EC and start at a predetermined time prior to the subjects entering the chamber and end after the last Time- weighted average TWA sampling is complete These will be visually monitored during chamber sessions days but will be recorded at a time starting immediately following the cohort has entered the chamber until TWA sampling is complete
During the CTS the air samples for time-weighted-average endpoints for selected analytes inside the EC will be acquired using individual pumped samplers installed at one location inside the EC for 2 hours starting immediately within 3 minutes after subjects exit the chamber for the Baseline without study product use and Test with study product use CTSs respectively These analytes include Respirable Suspended Particles RSP 25µm Ultraviolet Particulate Matter UVPM Florescence Particulate Matter FPM Solanesol Nicotine 3-ethenylpyridine 3-EP Ammonia Formaldehyde Acetaldehyde Benzene ortho-Cresol meta- and para-Cresol Ethylbenzene Glycerol Phenol Pyridine Pyrrole Styrene Toluene ortho-Xylene meta- and para-Xylene and TVOC-derived
The total duration of the study from the first subject check-in through the last subject check-out will be approximately 6 weeks approximately 42 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None