Room Air Levels of Harmful and Potentially Harmful Constituents After Heated Tobacco Product Use and Cigarettes

NCT06476405 | Completed

• 1 other identifier: ALCS-REG-23-10-HT
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Tobacco Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (28)

• 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

Study Arms (2)

Group 1 Non-Menthol

Product A: Heated Tobacco Product (HTP) denoted as Ploom PX1.5TN HTP; Tobacco HTS (Heated Tobacco Stick); R8. Test product sourced from Japan Tobacco Inc. Product B: UBCC Non-menthol (Usual Brand Combustible Cigarette) Reference product supplied by subject

Group 2 Menthol:

Product C: Heated Tobacco Product (HTP) denoted as Ploom PX1.5TN HTP; Menthol HTS (Heated Tobacco Stick); MX3. Test product sourced from Japan Tobacco Inc. Product D: UBCC Menthol (Usual Brand Combustible Cigarette). Reference product supplied by subject

Interventions

Study Product A: Ploom® Non-Menthol Flavor

Study Product B: Usual Brand Combustible Cigarette (UBCC) Non-Menthol Flavor

Study Product C: Ploom® Menthol Heated Tobacco Product (HTP)

Study Product D: Usual Brand Combustible Cigarette (UBCC) Menthol Flavor

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Combustible cigarette smokers

You may qualify if:

• Provides voluntary consent to participate in this study documented on the signed ICF.
• Adult, male or female, 22 to 65 years of age, inclusive, at the Screening visit.
• Able to communicate effectively with the study personnel and willing to comply with the requirements of the study.
• Subjects must be generally healthy, and without clinically significant abnormalities as assessed by the Investigator based on the review of medical and surgical history, physical examination, vital signs measurement, 12-lead ECG, and laboratory evaluations conducted at Screening (refer to Table 1).
• Screening blood pressure ≤ 150/90 mmHg measured after being seated for at least 10 minutes. Two rechecks may be performed at the Investigator's discretion.
• Urine cotinine ≥ 200 ng/mL at Screening.
• Exhaled carbon monoxide ≥ 10 ppm at Screening.
• Female subjects who are sexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to Screen nor postmenopausal with amenorrhea for at least 1 year prior to screen and FSH levels consistent with postmenopausal status) must not be lactating and must have been using 1 of the following forms of contraception from 3 months before study product administration through 30 days after the final administration of study product:
• Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to Check-in, when used in combination with male condoms with spermicide (use of NuvaRing® is at the Investigator's discretion)
• Double barrier (e.g., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to Check-in
• Intrauterine device or system (utilize Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to Check-in
• Exclusive partner who is clinically sterile (i.e., documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to Check-in Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in line with the preferred and usual lifestyle of the subject.
• Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
• Female subjects who are of non-childbearing potential must have undergone 1 of the following sterilization procedures at least 6 months prior to Check-in:
• Hysteroscopic sterilization with documentation of success with hysterosalpingogram

You may not qualify if:

• History or presence of any type of malignant tumor or clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening, as determined by the Investigator, that would impact the safety of the participant or the validity of the study results (e.g., hypertension, diabetes, asthma, or other lung disease, cardiac disease, neurological disease, psychiatric disorders).
• Current evidence or any history of congestive heart failure.
• Any other condition or prior therapy that, in the Investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
• Clinically significant abnormal vital sign, physical examination (including oral cavity an oropharynx), ECG, medical history, or clinical laboratory findings, in the opinion of the Investigator.
• Positive test for HIV-1 or HIV-2; or HbsAg or HCV consistent with current infection at Screening.
• An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to each study visit.
• Self-reported puffers (i.e., smokers who draw smoke from the combustible cigarette into the mouth and throat but do not inhale).
• Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening Visit) to participate in this study.
• Employees and first-degree relatives (i.e., parent, sibling, child, spouse) of the Sponsor and Sponsor representatives, a tobacco company, the study site, or the environmental test chamber vendor.
• Females who have a positive pregnancy test (at Screen and every visit), are pregnant, breastfeeding, or intend to become pregnant during the study.
• History of claustrophobia.
• History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse within 24 months prior to Screen
• Positive screen for alcohol (breath or urine) or any of the following drugs of abuse (urine), regardless of the reason of use: amphetamines, methamphetamines, opiates, or cocaine at Screening.
• Fever (i.e., body temperature \> 100.5 F) at Screening or every CTS visit; 1 recheck may be performed at the Investigator's discretion.
• Body mass index \> 40.0 kg/m2 or \< 18.0 kg/m2 at Screening (1).

Sponsors & Collaborators

• Altria Client Services LLC: lead
• ICON Clinical Research: collaborator

Study Sites (1)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 10, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 11, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)