Trial Outcomes & Findings for IQOS (Non-Cigarette Tobacco Product) Pilot Study (NCT NCT04357379)

NCT ID: NCT04357379

Last Updated: 2021-10-27

Results Overview

Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit
• Results posted on: 2021-10-27

Participant Flow

Participant milestones

Measure	IQOS Group IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IQOS (Non-Cigarette Tobacco Product) Pilot Study

Baseline characteristics by cohort

Measure	IQOS Group n=10 Participants IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Age, Continuous	37.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit

Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette

Outcome measures

Measure	IQOS Group n=10 Participants IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Number of Participants Who Prefer IQOS	7 Participants

SECONDARY outcome

Timeframe: Week 2 of study

The average percent reduction in cigarettes per day observed in Week 2

Outcome measures

Measure	IQOS Group n=10 Participants IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Cigarettes Per Day	16.1 Percentage reduction in cigs per day Standard Deviation 32.7

Adverse Events

IQOS Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IQOS Group n=10 participants at risk IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
General disorders Cough	10.0% 1/10 • Number of events 2 • 2 weeks Interviewer-administered assessment at each visit
General disorders Headache	10.0% 1/10 • Number of events 1 • 2 weeks Interviewer-administered assessment at each visit
General disorders Nausea	10.0% 1/10 • Number of events 1 • 2 weeks Interviewer-administered assessment at each visit
General disorders ER visit for medication refill	10.0% 1/10 • Number of events 1 • 2 weeks Interviewer-administered assessment at each visit

Additional Information

Dr. Tracy Smith

Medical University of South Carolina

Phone: 8437925164

Email: smithtra@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place