Trial Outcomes & Findings for Heated Tobacco Products vs Electronic Cigarettes (NCT NCT03569748)

Results Overview

to compare the efficacy of HTP and EC, in terms of quit rates at week 12, by self-reporting abstinence from classic cigarette \[validated by an Exhaled breath Carbon monoxide (eCO) measurement ≤10ppm)\]

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

220 participants

Primary outcome timeframe

12 WEEK

Results posted on

2021-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	IQOS HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Overall Study STARTED	110	110
Overall Study COMPLETED	110	101
Overall Study NOT COMPLETED	0	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heated Tobacco Products vs Electronic Cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=110 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS	Total n=220 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 16.1 • n=99 Participants	41.3 years STANDARD_DEVIATION 16.9 • n=107 Participants	41.3 years STANDARD_DEVIATION 16.5 • n=206 Participants
Sex: Female, Male Female	54 Participants n=99 Participants	40 Participants n=107 Participants	94 Participants n=206 Participants
Sex: Female, Male Male	56 Participants n=99 Participants	70 Participants n=107 Participants	126 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	110 Participants n=99 Participants	110 Participants n=107 Participants	220 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 WEEK

to compare the efficacy of HTP and EC, in terms of quit rates at week 12, by self-reporting abstinence from classic cigarette \[validated by an Exhaled breath Carbon monoxide (eCO) measurement ≤10ppm)\]

Outcome measures

Outcome measures
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=107 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Number of Participants With Smoking Cessation	60 Participants	44 Participants

SECONDARY outcome

Timeframe: Week 12

To compare the smoking reduction derived from the use of HTP and EC, intended as a 50% reduction in the number of conventional cigarette/day at week 12, defined through self-reporting;

Outcome measures

Outcome measures
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=107 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Number of Participants Smoking Reduction	100 Participants	77 Participants

SECONDARY outcome

Timeframe: Week 12

To compare the adoption rate to product use \[by collecting (empty) refill bottles and used heathsticks on a daily basis, verified by a study diary filled daily by the subject\];

Outcome measures

Outcome measures
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=107 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Adoption Rate	102 Participants	84 Participants

SECONDARY outcome

Timeframe: Week 12

To compare the acceptability derived from the use of HTP and EC by the modified Cigarette Evaluation Questionnaire (mCEQ). It is a self-administered questionnaire that contains 12 items covering both reinforcing and aversive effects of smoking. The items are rated on a 7-point scale from 1 not at all to 7 extremely The total mCEQ score range from min 12 to max 84. Higher scores for the total mCEQ reflect a better outcome. There are also the following 5 subscales: 1. Smoking Satisfaction (items 1, 2, 12) range of scores min 3 max 21;higher scores mean a better outcome. 2. Psychological Reward (items 4-8), range of scores min 5 max 35; higher scores mean a better outcome. 3. Aversion (items 9 and 10), range of scores min 2 max 14;higher scores mean a worse outcome. 4. Single item score Enjoyment Respiratory Tract Sensations (item 3) range scores min 1 max 7;higher scores mean a better outcome. 5. Single item score Craving Reduction (item 11), higher scores mean a better outcome

Outcome measures

Outcome measures
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=107 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Acceptability	0.73 score on a scale Interval -1.04 to 2.49	-0.17 score on a scale Interval -1.77 to 1.44

SECONDARY outcome

Timeframe: Week 12

To compare number of participants with adverse events derived from the use of HTP and EC as assessed by CTCAE v4.0

Outcome measures

Outcome measures
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=110 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Number of Participants With Product-related Adverse Events	20 Participants	24 Participants

SECONDARY outcome

Timeframe: Week 12

changes in Biomarkers of Biological Effects (BoBE) such as: eCO in the exhaled breath (i.e. eCO), step test values

Outcome measures

Outcome measures
Measure	IQOS n=110 Participants HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=107 Participants ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Changes in Biomarkers of Biological Effects (BoBE)	8.2 ppm Standard Deviation 8.0	10.1 ppm Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline visit, Week 12

To compare the reliability of HTP and EC, in terms of incidence and kind of malfunctioning events, through self-reporting.

Outcome measures

Outcome data not reported

Adverse Events

IQOS

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

E-CIG

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IQOS n=110 participants at risk HEAT NOT BURN REDUCED RISK PRODUCT IQOS: IQOS USE FOR 12 WEEKS	E-CIG n=110 participants at risk ELECTRONIC CIGARETTE REDUCED RISK PRODUCT E-CIG: ELECTRONIC CIGARETTE FOR 12 WEEKS
Respiratory, thoracic and mediastinal disorders Cough	24.5% 27/110 • Number of events 27 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality	21.8% 24/110 • Number of events 24 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality
General disorders Fatigue	19.1% 21/110 • Number of events 21 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality	10.9% 12/110 • Number of events 12 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.3% 8/110 • Number of events 8 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality	13.6% 15/110 • Number of events 15 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 4/110 • Number of events 4 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality	6.4% 7/110 • Number of events 7 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality
Respiratory, thoracic and mediastinal disorders Palpitations	3.6% 4/110 • Number of events 4 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality	3.6% 4/110 • Number of events 4 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality
Respiratory, thoracic and mediastinal disorders Catarrh	2.7% 3/110 • Number of events 3 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality	4.5% 5/110 • Number of events 5 • 3 months Any participants showed/reported signs and symptoms considered serious by the medical investigators with absence of all-cause of mortality

Additional Information

Maria Signorelli

University of Catania

Phone: 095.378.2636/794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place