Room Air Levels of Harmful and Potentially Harmful Constituents After Heated Tobacco Product Use and Cigarettes
NCT Number: NCT06476405
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Smoking|Tobacco Use
Interventions: OTHER: Study Product A: Ploom® Non-Menthol Flavor|OTHER: Study Product B: Usual Brand Combustible Cigarette (UBCC) Non-Menthol Flavor|OTHER: Study Product C: Ploom® Menthol Heated Tobacco Product (HTP)|OTHER: Study Product D: Usual Brand Combustible Cigarette (UBCC) Menthol Flavor
Sponsor: Altria Client Services LLC
Collaborators: ICON Clinical Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2025-01
Locations: Clinical Research Atlanta, Stockbridge, Georgia, 30281, United States

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).

Primary Outcome Measures: Carbon Dioxide (Parts per Million, PPM), Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS., Day 0, Day 1|Carbon Monoxide (Parts per Million, PPM), Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS., Day 0, Day 1|Relative Humidity (%), Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS., Day 0, Day 1|Total Volatile Organic Compounds (TVOC) (Parts per Million, PPM), Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS., Day 0, Day 1|Temperature (degrees Centigrade, °C), Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS. Expected to maintain 22 +/- 2°C during the CTS., Day 0, Day 1|Air Exchange Rate (AER), Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS. Derived value using formula: AER = Q (volumetric air flow in cubic feet per minute)/V (volume of the room in cubic meters). The AER is expected to be static for the duration of the CTS., Day 0, Day 1|Respirable Suspended Particles (RSP) (mg), Measured by aerosol analysis of air samples collected during the CTS. Analysis performed using method described in CORESTA Recommended Method No 51 CRM_51 (coresta.org) and with expected value range 0.011 - 250 mg., Day 0, Day 1|Ultraviolet Particulate Matter (UVPM) (µg/ m3), Measured by aerosol analysis of air samples collected during the CTS. Analysis performed using method described in CORESTA Recommended Method No 51 CRM_51 (coresta.org) and with expected value range .0.16 - 6.40 µg/mL. Analytical output will be converted to µg/ m3, Day 0, Day 1|Florescence Particulate Matter (FPM) (µg/ m3), Measured by aerosol analysis of air samples collected during the CTS. Analysis performed using method described in CORESTA Recommended Method No 51 CRM_51 (coresta.org) and with expected value range 0.0035 - 3.50 µg/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Nicotine (mg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in CORESTA Recommended Method No 50 CRM_50.pdf (coresta.org) with expected value range of 0.096 - 4.80 µg/mL. Analytical output will be converted to mg/ m3., Day 0, Day 1|3-ethenylpyridine (3-EP) (mg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in CORESTA Recommended Method No 50 CRM_50.pdf (coresta.org) with expected value range of 0.04 - 2.4 µg/mL. Analytical output will be converted to mg/ m3., Day 0, Day 1|Ammonia (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in NIOSH Method 6016 Issue 2, Ammonia by IC NMAM METHOD 6016 (cdc.gov) with expected value range of 15 - 70 µg/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Formaldehyde (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described inASTM D5197 - 16 D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology) (astm.org) with expected value range of 0.0912 - 2.86 µg/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Acetaldehyde (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in ASTM D5197 - 16 D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology) (astm.org) with expected value range of 0.126 - 3.94 µg/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Benzene (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in range of 20 - 700 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|ortho-Cresol (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in the range of 10.0 - 702.8 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|meta- and para-Cresol (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected results in the range of 10.0 - 702.2 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Ethylbenzene (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in range of 2.0 - 700 ng/mL . Analytical output will be converted to µg/ m3., Day 0, Day 1|Glycerol (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected results in the range of 140.4 - 200.5 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Propylene Glycol (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with the expected results in the range of 399.2 - 13972 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Phenol (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with the results expected in the range of 19.97 - 698.9 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Pyridine (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in range of 5.02 - 702.8 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Pyrrole (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in the range of 5.01 - 700.7 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Styrene (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in range of 9.96 - 697.7 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Toluene (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected values in range of 5.0 - 700 ng/mL . Analytical output will be converted to µg/ m3., Day 0, Day 1|ortho-Xylene (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected results in the range of 1.99 - 698.7 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1.|meta- and para-Xylene (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in EPA TO-17, Second Edition (EPA/625/R-96/010b), Method TO-17 - Determination of Volatile Organic Compounds in Ambient Air Using Active Sampling Onto Sorbent Tubes (epa.gov) with expected results in the range of 2.00 - 700.3 ng/mL. Analytical output will be converted to µg/ m3., Day 0, Day 1|Solanesol (µg/ m3), Measured by aerosol analysis of air samples collected during CTS. Analysis performed using procedures described in CORESTA Recommended Method No 52 Environmental Tobacco Smoke - Estimation of its Contribution to Respirable Suspended Particles - Method based on Solanesol Determination \| CORESTA with expected results in the range of 0.135 - 16.8 µg/mL. Analytical output will be converted to µg/ m3, Day 0, Day 1