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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Carbon Monoxide (Parts per Million, PPM)
研究概览
简要总结
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).
详细描述
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 U.S. FDA list of HPHCs, compounds from the WHO priority list of toxicants, constituents with relevance for air quality, and product-specific markers. There is no formal hypothesis for this observational study.
The study products include the following:
Product A: Ploom PX1.5TN HTP; Tobacco HTS; R8 (Test product)
Product B: Non-menthol UBCC (Usual Brand Combustible Cigarette); Reference product supplied by subjects
Product C: Ploom PX1.5TN HTP; Menthol HTS; MX3 (Test product)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must meet all of the following inclusion criteria to be eligible for participation in the study:
- •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.
- •Self-reports at the Screening Visit smoking at least 5 non-menthol or menthol combustible cigarettes per day for at least 12 months prior to Screening. [Prior to screening, brief periods (i.e., up to 7 consecutive days) of non-smoking within 90 days before Check-in (e.g., due to illness or participation in a clinical study where tobacco use was prohibited) will not be exclusionary at the discretion of the Investigator (other non-daily tobacco use, except for heated tobacco use, within 30 days prior to screening are not exclusionary)].
- •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
- •Bilateral tubal ligation or bilateral salpingectomy
- •Hysterectomy
- •Bilateral oophorectomy
- •Essure® or, be postmenopausal with amenorrhea for at least 1 year prior to Screen and confirmed by FSH levels consistent with postmenopausal status.
排除标准
- •Individuals who meet any of the following exclusion criteria will not be enrolled in the study:
- •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.
- •Diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the Investigator. Fasting plasma glucose > 126 mg/dL [7 mmol/L] is exclusionary. One recheck may be performed for fasting plasma glucose values > 126 mg/dL but < 200 mg/dL.
- •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).
- •Estimated glomerular filtration rate < 80 mL/minute using the CKD-EPI (2) formula at Screening.
- •Use of prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral ß agonists) for treatment of any illness within 12 months prior to Screen.
- •Currently participating in another clinical study; or participation in > 2 ALCS-sponsored studies within the past 12-month period prior to Screen.
- •Negative response (i.e., unwilling to use or unable to tolerate [e.g., experiences AEs during the Product Trial that will prevent the subject from continuing to use the product as judged by the Investigator]) to the product during the Product Trial visit.
- •Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini mart employee).
- •Unable to communicate or unwilling to cooperate with the clinical staff in the opinion of the Investigator.
研究组 & 干预措施
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
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
结局指标
主要结局
Carbon Monoxide (Parts per Million, PPM)
时间窗: Day 0, Day 1
Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS.
Benzene (µg/ m3)
时间窗: Day 0, Day 1
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.
meta- and para-Cresol (µg/ m3)
时间窗: Day 0, Day 1
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.
Relative Humidity (%)
时间窗: Day 0, Day 1
Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS.
Total Volatile Organic Compounds (TVOC) (Parts per Million, PPM)
时间窗: Day 0, Day 1
Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS.
Carbon Dioxide (Parts per Million, PPM)
时间窗: Day 0, Day 1
Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS.
Temperature (degrees Centigrade, °C)
时间窗: Day 0, Day 1
Air quality measure collected via environmental chamber (EC) internal sensor and continuously recorded during CTS. Expected to maintain 22 +/- 2°C during the CTS.
Air Exchange Rate (AER)
时间窗: Day 0, Day 1
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.
Ammonia (µg/ m3)
时间窗: Day 0, Day 1
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.
ortho-Cresol (µg/ m3)
时间窗: Day 0, Day 1
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.
Formaldehyde (µg/ m3)
时间窗: Day 0, Day 1
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.
Acetaldehyde (µg/ m3)
时间窗: Day 0, Day 1
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.
Ethylbenzene (µg/ m3)
时间窗: Day 0, Day 1
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.
Glycerol (µg/ m3)
时间窗: Day 0, Day 1
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.
Propylene Glycol (µg/ m3)
时间窗: Day 0, Day 1
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.
Phenol (µg/ m3)
时间窗: Day 0, Day 1
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.
Pyridine (µg/ m3)
时间窗: Day 0, Day 1
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.
Pyrrole (µg/ m3)
时间窗: Day 0, Day 1
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.
Toluene (µg/ m3)
时间窗: Day 0, Day 1
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.
Styrene (µg/ m3)
时间窗: Day 0, Day 1
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.
Solanesol (µg/ m3)
时间窗: Day 0, Day 1
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
ortho-Xylene (µg/ m3)
时间窗: Day 0, Day 1.
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.
meta- and para-Xylene (µg/ m3)
时间窗: Day 0, Day 1
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.
Respirable Suspended Particles (RSP) (mg)
时间窗: Day 0, Day 1
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.
Ultraviolet Particulate Matter (UVPM) (µg/ m3)
时间窗: Day 0, Day 1
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
Florescence Particulate Matter (FPM) (µg/ m3)
时间窗: Day 0, Day 1
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.
Nicotine (mg/ m3)
时间窗: Day 0, Day 1
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.
3-ethenylpyridine (3-EP) (mg/ m3)
时间窗: Day 0, Day 1
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.
次要结局
未报告次要终点