CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted … (NCT05363254) | Clinical Trial Compass
CompletedNot Applicable
CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Environmental Testing Chamber
United States120 participantsStarted 2022-05-23
Plain-language summary
This is a single-center, open-label, parallel-cohort study to measure and compare the levels of selected secondhand smoke (SHS) constituents of a heated tobacco product (HTP) against combustible cigarettes (CC) after ad libitum smoking sessions by generally healthy smokers in an environmental testing chamber (ETC). Evaluation of SHS constituents detected during non-smoking sessions will be performed as a control.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to read, understand, and willing to sign an informed consent form (ICF) and complete any questionnaires written in English.
. Generally healthy male or female adults, 21 years of age or older, inclusive, at the time of signing the ICF.
. Self-reports at the Screening Visit smoking at least 5 cigarettes per day and inhaling the smoke, for at least 3 months prior to the Screening Visit. Users of HTPs that smoke at least 5 sticks per day will also be allowed into the study. Dual users of combustible cigarettes (CC) and HTPs (either 5 combustible cigarettes or 5 HTP sticks per day, or a combination of 5 CC/HTP products per day) will also be allowed into the study.
. Positive urine cotinine test at the Screening Visit.
. Smokes any commercially available brand cigarette as their UB. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject. Users of HTPs will also be allowed into the study. Specific brand users must meet the following cohort-specific requirements:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Real-time and time-weighted average (TWA) concentrations of Acetaldehyde
Timeframe: 20 minutes
2
Real-time and time-weighted average (TWA) concentrations of Ammonia (NH3)
Timeframe: 20 minutes
3
Real-time and time-weighted average (TWA) concentrations of Benzene
Timeframe: 20 minutes
4
Real-time and time-weighted average (TWA) concentrations of Carbon monoxide (CO)
Timeframe: 20 minutes
5
Real-time and time-weighted average (TWA) concentrations of Formaldehyde
Timeframe: 20 minutes
6
Real-time and time-weighted average (TWA) concentrations of Nicotine
Timeframe: 20 minutes
7
Real-time and time-weighted average (TWA) concentrations of Toluene
. Cohort 1: Self-reports smoking Marlboro Gold Box as their UB and willing to smoke self-provided UB cigarettes for the duration of the study.
. Cohort 2: Self-reports smoking Newport Box as their UB and willing to smoke self-provided UB cigarettes for the duration of the study.
. Cohorts 3 through 8: Self-reports smoking any style of menthol cigarette as their UB and willing to use a menthol non-combusted cigarette variant ad libitum for the duration of the study. Users of menthol HTPs will also be allowed into this cohort.
Exclusion criteria
. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.
. History of, presence of, or clinical laboratory test results indicating diabetes.
. Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes.
. Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be allowed at the PI's discretion, pending approval from the Medical Monitor.
. Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed.
. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
. Participation in another clinical trial within (≤) 30 days prior to signing the ICF. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
. Females who have a positive pregnancy test, or who are pregnant, are breastfeeding, or intend to become pregnant during the course of the study.
Real-time and time-weighted average (TWA) concentrations of Respirable suspended particulates (RSP) (PM2.5)