Puff Topography and Sensory Effects Across IQOS Device Generations
13 luglio 2026 aggiornato da: American University of Beirut Medical Center
Puff Topography and Sensory Effects Across IQOS Device Generations: A Randomized Crossover Study
The goal of this clinical trial is to learn how people use two generations of IQOS heated tobacco devices and how each device affects their smoking behavior and sensory experience.
The main questions it aims to answer are:
- Do participants puff differently when using the newer IQOS Iluma i compared to the older IQOS 2.4?
- Does the flavor of the tobacco stick (preferred flavor vs. standard tobacco flavor) affect puffing behavior or sensory experience?
- What are the differences in throat hit, mouthfeel, and satisfaction between the two devices?
Participants will:
- Attend 2 laboratory visits at the American University of Beirut
- Use both the IQOS Iluma i and IQOS 2.4 devices during each visit
- Have their puffing behavior recorded automatically during device use
- Provide a breath sample before and after each use session
- Complete short questionnaires about how each device felt and their urge to smoke
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Heated tobacco products (HTPs) such as IQOS have evolved across generations, with newer models using induction-based heating rather than a ceramic blade.
Nicotine yields have declined across generations, raising the possibility that sensory characteristics have been modified to maintain product appeal.
Current emissions assessments rely on standardized machine-puffing regimens derived from cigarette testing, which may not reflect real-world IQOS user behavior.
This study will characterize puff topography (volume, duration, flow rate, inter-puff interval, number of puffs) in 50 exclusive IQOS users during ad-libitum use of the IQOS Iluma i and IQOS 2.4 under preferred and standardized (Amber) flavor conditions.
A randomized crossover design with two visits will be used, with device order within each visit randomized using a Williams design.
Secondary outcomes include chemosensory ratings (mouthfeel, ease of draw, throat hit), and subjective effects (satisfaction, pleasantness, taste, urges).
Data will inform device-specific puffing regimens for use in future emissions assessments.
Tipo di studio
Interventistico
Iscrizione (Stimato)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Soha Talih, PhD
- Numero di telefono: 3627 +961-1-350000
- Email: st38@aub.edu.lb
Backup dei contatti dello studio
- Nome: Mario El Hourani, PhD
- Numero di telefono: +96170715263
- Email: me217@aub.edu.lb
Luoghi di studio
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Beirut, Libano
- Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Current IQOS user (at least 3 days per week in the past 30 days)
- Age 18 to 65 years
- Generally healthy
- Willing to provide informed written consent
- Willing to attend all laboratory visits
- Willing to abstain from all nicotine and tobacco products for at least 12 hours before each visit
Exclusion Criteria:
- Use of any tobacco products other than IQOS in the past 30 days
- Chronic cardiovascular conditions, seizures, or abnormal blood pressure
- Current psychiatric disorder requiring active treatment, including major depressive disorder
- Regular use of prescription medications that may influence cardiovascular function, respiratory function, or nicotine metabolism (excluding vitamins or birth control)
- Use of cocaine, opioids, benzodiazepines, or methamphetamines in the past month
- Marijuana use on more than 15 days per month
- Current pregnancy or breastfeeding
- Plans to quit nicotine or tobacco products within the next 30 days
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: IQOS Iluma i (Induction Heating)
Participants use the IQOS Iluma i device with TEREA tobacco sticks under two flavor conditions (preferred flavor and standardized Amber flavor) across study visits.
The IQOS Iluma i uses induction-based heating technology.
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The IQOS Iluma i is an induction-heated tobacco device used with TEREA STICKS.
Participants use the device ad libitum during two smoking bouts (preferred flavor and Amber flavor conditions) across two study visits.
Puff topography is recorded continuously during use.
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Comparatore attivo: IQOS 2.4 (Blade Heating)
Participants use the IQOS 2.4 device with HEETS tobacco sticks under two flavor conditions (preferred flavor and standardized Amber flavor) across study visits.
The IQOS 2.4 uses ceramic blade heating technology.
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The IQOS 2.4 is a ceramic blade-heated tobacco device used with HEETS tobacco sticks.
Participants use the device ad libitum during two smoking bouts (preferred flavor and Amber flavor conditions) across two study visits.
Puff topography is recorded continuously during use.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Chemosensory Effects - Mouthful
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (1) Mouthful - amount of aerosol filling the mouth, rated on a 1-5 visual analog scale (1 = barely any smoke to 5 = a lot of smoke); higher scores indicate greater mouthful sensation.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects - Ease of draw
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (2) Ease of draw - effort required to draw a puff, rated on a 1-5 visual analog scale (1 = easy to 5 = hard); higher scores indicate greater effort required.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects - Throat hit
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (3) Throat hit - intensity of throat sensation, rated on a 0-100 General Labeled Magnitude Scale (0 = barely detectable to 100 = strongest imaginable); higher scores indicate greater throat hit intensity.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean Puff Duration
Lasso di tempo: Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean duration (seconds) of each puff recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
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Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Number of Puffs Per Stick
Lasso di tempo: Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Total number of puffs taken per tobacco stick during each ad-libitum smoking bout, recorded using the eTOP puff topography instrument.
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Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean Inter-Puff Interval
Lasso di tempo: Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean time (seconds) between the end of one puff and the start of the next, recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
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Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean Puff Flow Rate
Lasso di tempo: Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean peak puff flow rate (mL/s) recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
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Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Urge to Use IQOS - Factor 1: desire/intention
Lasso di tempo: Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Urge to use IQOS assessed using a 10-item adaptation of the Questionnaire on Smoking Urges-Brief (QSU-Brief), rated on a 7-point scale (1 = Strongly Disagree to 7 = Strongly Agree).
Higher scores indicate greater urge to use IQOS.
Total score and subscale scores (Factor 1: desire/intention; Factor 2: negative reinforcement) will be reported.
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Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Urge to Use IQOS - Factor 2: negative reinforcement
Lasso di tempo: Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Urge to use IQOS assessed using a 10-item adaptation of the Questionnaire on Smoking Urges-Brief (QSU-Brief), rated on a 7-point scale (1 = Strongly Disagree to 7 = Strongly Agree).
Higher scores indicate greater urge to use IQOS.
Total score and subscale scores (Factor 1: desire/intention; Factor 2: negative reinforcement) will be reported.
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Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - satisfaction
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - taste
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - throat/chest sensations
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - calm
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - awake
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - irritable
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - concentration
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - hungry
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - dizziness
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - nausea
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - craving relief
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
|
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - enjoyment
Lasso di tempo: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
|
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely).
Higher scores indicate greater intensity of the effect.
Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment.
Each item is reported individually.
The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Soha Talih, American University of Beirut Medical Center
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
20 luglio 2026
Completamento primario (Stimato)
1 ottobre 2027
Completamento dello studio (Stimato)
15 dicembre 2027
Date di iscrizione allo studio
Primo inviato
3 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 luglio 2026
Primo Inserito (Effettivo)
20 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BIO-2026-0012
- AUB (Altro numero di sovvenzione/finanziamento: American University of Beirut)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be shared.
Data are stored on password-protected institutional computers at the American University of Beirut and are accessible only to authorized study personnel.
Data may be made available to qualified researchers upon reasonable request to the corresponding author.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su IQOS Iluma i with TEREA Tobacco Sticks
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Philip Morris Products S.A.CompletatoFumare | Uso del tabacco | Fumo di tabaccoRegno Unito