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Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887117
Recruitment Status : Completed
First Posted : March 22, 2019
Results First Posted : December 27, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Smoking
Exercise Capacity
Interventions Other: IQOS + Exercise Training Program
Other: IQOS without Exercise Training Program
Other: Cigarette Smoking + Exercise Training Program
Other: Smoking Abstinence + Exercise Training Program
Enrollment 94
Recruitment Details  
Pre-assignment Details

94 subjects were enrolled into the study, but 1 subject was not randomized. 26 subjects were randomized to Cigarette arm, 25 subjects were randomized to IQOS-1 arm, 15 subjects to IQOS-2 arm, and 27 subjects to the Smoking Abstinence (SA) arm.

Subjects were requested to use the product allocated to their respective study arm, but it was considered acceptable that not all subjects randomized to the IQOS arms or to the cigarette arm exclusively used the randomized product during the study.

Arm/Group Title IQOS-1 IQOS-2 Cigarette Smoking Smoking Abstinence
Hide Arm/Group Description

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program

Period Title: Overall Study
Started 25 15 26 27
Completed 25 14 25 25
Not Completed 0 1 1 2
Reason Not Completed
Discontinued prematurely             0             1             1             2
Arm/Group Title IQOS-1 IQOS-2 Cigarette Smoking Smoking Abstinence Total
Hide Arm/Group Description

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program

No Training

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

No Training: Switch to IQOS use only, without participation in a training program

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program

Total of all reporting groups
Overall Number of Baseline Participants 24 14 25 27 90
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 14 participants 25 participants 27 participants 90 participants
38.8  (12.8) 40.5  (13.4) 40.0  (10.9) 40.2  (10.3) 39.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 14 participants 25 participants 27 participants 90 participants
Female
12
  50.0%
7
  50.0%
14
  56.0%
16
  59.3%
49
  54.4%
Male
12
  50.0%
7
  50.0%
11
  44.0%
11
  40.7%
41
  45.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 14 participants 25 participants 27 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
24
 100.0%
14
 100.0%
25
 100.0%
27
 100.0%
90
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 24 participants 14 participants 25 participants 27 participants 90 participants
171  (10.3) 171  (10.4) 171  (8.25) 171  (9.19) 171  (9.27)
Cigarettes smoked/day (last year)  
Mean (Standard Deviation)
Unit of measure:  Cigarettes/day
Number Analyzed 24 participants 14 participants 25 participants 27 participants 90 participants
18.8  (5.51) 17.2  (4.3) 18.0  (4.69) 18.9  (6.66) 18.4  (5.46)
1.Primary Outcome
Title Maximal Oxygen Uptake (VO2max, Absolute Values)
Hide Description To measure VO2max during maximal cycle ergometer exercise (expressed in absolute values [mL*min-1]).
Time Frame Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: mL/min
Acute Baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
1878
(1715 to 2040)
2027
(1799 to 2255)
2197
(1788 to 2605)
1950
(1708 to 2191)
2750 1620
2103
(1775 to 2430)
Acute Effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
1823
(1686 to 1960)
2062
(1823 to 2300)
2156
(1747 to 2565)
2071
(1791 to 2351)
2770 1770
2094
(1721 to 2466)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
1977
(1807 to 2147)
2178
(1889 to 2468)
2150
(1709 to 2591)
2292
(1984 to 2601)
2182
(1628 to 2736)
2.Primary Outcome
Title Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)
Hide Description To measure VO2max during maximal cycle ergometer exercise (expressed in weight-adjusted [mL*kg-1*min-1] values).
Time Frame Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: mL/(kg*min)
Acute Baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
27.3
(24.8 to 29.8)
27.4
(24.9 to 29.9)
28.9
(24.6 to 33.3)
25.1
(22.9 to 27.3)
34.7 24.4
25.8
(21.8 to 29.8)
Acute Effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
26.6
(24.4 to 28.8)
27.9
(25.1 to 30.7)
28.2
(24.4 to 32.0)
26.7
(24.0 to 29.4)
34.5 27.0
25.4
(21.3 to 29.5)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
27.9
(25.1 to 30.8)
28.8
(25.7 to 31.8)
27.7
(23.1 to 32.3)
29.6
(26.4 to 32.7)
30.9
(27.9 to 34.0)
3.Primary Outcome
Title Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)
Hide Description To measure VO2max during maximal cycle ergometer exercise (expressed in fat-free weight adjusted values [mL*kg-1*min-1]).
Time Frame Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: mL/(kg*min)
Acute Baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
37.5
(34.4 to 40.5)
38.4
(35.3 to 41.6)
38.3
(34.0 to 42.6)
34.8
(32.7 to 36.9)
44.1 34.3
34.4
(29.5 to 39.3)
Acute Effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
37.0
(33.8 to 40.2)
39.8
(35.6 to 44.0)
37.6
(34.3 to 41.0)
37.0
(34.6 to 39.5)
45.3 40.2
34.1
(30.1 to 38.1)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
40.3
(36.4 to 44.2)
39.8
(36.5 to 43.1)
38.1
(34.4 to 41.8)
42.0
(38.7 to 45.2)
44.7
(36.2 to 53.1)
4.Primary Outcome
Title Exercise Capacity
Hide Description To measure exercise capacity, by measuring time to complete a pre-defined work (determined as 25% more work than the study subject produced during baseline VO2max test) on a cycle ergometer (seconds).
Time Frame Measured at baseline (V3), at week 1 (V4), and at week 12 (V43)
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: seconds
Acute Baseline (V3) Number Analyzed 19 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
2283
(2033 to 2534)
2366
(2109 to 2623)
2330
(2013 to 2648)
2156
(1975 to 2337)
2110 2871
2147
(1722 to 2571)
Acute Effect (V4) Number Analyzed 19 participants 14 participants 12 participants 19 participants 1 participants 1 participants 8 participants
2205
(2017 to 2394)
2189
(1949 to 2429)
2170
(1877 to 2462)
2210
(1921 to 2498)
2402 3006
2190
(1820 to 2561)
Training Effect (V43) Number Analyzed 19 participants 18 participants 11 participants 21 participants 0 participants 0 participants 4 participants
1985
(1728 to 2242)
2123
(1926 to 2319)
2374
(1970 to 2777)
1849
(1623 to 2075)
1982
(1465 to 2498)
5.Primary Outcome
Title Exercise Training Intensity: Cumulative Work
Hide Description To measure cumulative work (calories) produced during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Time Frame Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 22 5
Mean (95% Confidence Interval)
Unit of Measure: calorie
Baseline (V5) Number Analyzed 21 participants 19 participants 21 participants 4 participants
169
(145 to 193)
222
(196 to 249)
208
(176 to 239)
203
(108 to 297)
V14 Number Analyzed 21 participants 18 participants 22 participants 4 participants
203
(175 to 231)
196
(167 to 226)
231
(200 to 261)
195
(135 to 255)
V29 Number Analyzed 21 participants 19 participants 22 participants 3 participants
183
(155 to 211)
197
(159 to 235)
223
(196 to 249)
214
(186 to 243)
V41 Number Analyzed 20 participants 18 participants 20 participants 3 participants
187
(161 to 212)
199
(169 to 230)
211
(183 to 239)
219
(80.5 to 357)
6.Primary Outcome
Title Exercise Training Intensity: Average Work Rate
Hide Description To measure the average work rate (watt) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Time Frame Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 22 5
Mean (95% Confidence Interval)
Unit of Measure: Watt
Baseline (V5) Number Analyzed 21 participants 19 participants 21 participants 4 participants
70.7
(61.1 to 80.3)
87.6
(77.2 to 98.0)
84.4
(71.1 to 97.8)
82.8
(44.9 to 121)
V14 Number Analyzed 21 participants 18 participants 22 participants 4 participants
81.7
(69.8 to 93.7)
78.7
(66.9 to 90.6)
90.5
(78.3 to 103)
80.5
(55.4 to 106)
V29 Number Analyzed 21 participants 19 participants 22 participants 3 participants
74.0
(63.1 to 84.8)
80.4
(64.7 to 96.2)
90.9
(80.3 to 101)
85.3
(54.5 to 116)
V41 Number Analyzed 20 participants 18 participants 20 participants 3 participants
76.9
(66.3 to 87.5)
82.1
(69.4 to 94.8)
85.8
(74.0 to 97.5)
89.0
(29.2 to 149)
7.Primary Outcome
Title Exercise Training Intensity: Average Heart Rate
Hide Description To measure the average heart rate (bpm) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Time Frame Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 22 5
Mean (95% Confidence Interval)
Unit of Measure: beats/minute
Baseline (V5) Number Analyzed 21 participants 19 participants 21 participants 4 participants
125
(119 to 131)
127
(122 to 132)
123
(117 to 128)
110
(77.7 to 142)
V14 Number Analyzed 21 participants 18 participants 22 participants 4 participants
119
(108 to 130)
127
(121 to 133)
121
(117 to 126)
125
(120 to 130)
V29 Number Analyzed 21 participants 19 participants 22 participants 3 participants
124
(116 to 131)
124
(118 to 130)
121
(116 to 125)
123
(113 to 133)
V41 Number Analyzed 20 participants 18 participants 20 participants 3 participants
125
(119 to 130)
122
(115 to 130)
123
(118 to 128)
120
(98.0 to 141)
8.Primary Outcome
Title Exercise Training Intensity: Time Spent at Maximal Heart Rate
Hide Description To measure the time (seconds) spent at 0-50%, 50-60%, 60-70%, 70-80 % and >80% of maximal heart rate during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Time Frame Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 22 5
Mean (95% Confidence Interval)
Unit of Measure: seconds
V5 (Baseline): 0-50% Number Analyzed 19 participants 19 participants 21 participants 4 participants
33.7
(1.00 to 66.4)
26.1
(-7.68 to 59.8)
14.2
(-2.15 to 30.5)
361
(-346 to 1068)
V5 (Baseline): 50-60% Number Analyzed 19 participants 19 participants 21 participants 4 participants
29.7
(6.05 to 53.3)
42.2
(14.7 to 69.7)
38.6
(18.3 to 58.9)
162
(-154 to 479)
V5 (Baseline): 60-70% Number Analyzed 19 participants 19 participants 21 participants 4 participants
86.1
(43.8 to 128)
130
(84.2 to 176)
131
(78.0 to 184)
301
(-242 to 843)
V5 (Baseline): 70-80% Number Analyzed 19 participants 19 participants 21 participants 4 participants
793
(615 to 971)
737
(586 to 888)
743
(564 to 923)
591
(378 to 803)
V5 (Baseline): >80% Number Analyzed 19 participants 19 participants 21 participants 4 participants
1438
(1193 to 1683)
1405
(1218 to 1591)
1415
(1179 to 1650)
944
(-372 to 2260)
Visit 14: 0-50% Number Analyzed 19 participants 17 participants 21 participants 4 participants
12.4
(0.479 to 24.4)
7.24
(2.73 to 11.7)
13.5
(4.26 to 22.8)
7.0
(-15.3 to 29.3)
Visit 14: 50-60% Number Analyzed 19 participants 17 participants 21 participants 4 participants
25.3
(9.05 to 41.6)
32.1
(15.0 to 49.3)
38.0
(21.9 to 54.1)
28.5
(-2.07 to 59.1)
Visit 14: 60-70% Number Analyzed 19 participants 17 participants 21 participants 4 participants
145
(22.7 to 267)
139
(82.5 to 195)
188
(80.8 to 295)
77.8
(-50.1 to 206)
Visit 14: 70-80% Number Analyzed 19 participants 17 participants 21 participants 4 participants
807
(616 to 997)
783
(606 to 960)
880
(691 to 1068)
888
(430 to 1346)
Visit 14: >80% Number Analyzed 19 participants 17 participants 21 participants 4 participants
1370
(1100 to 1641)
1424
(1197 to 1650)
1260
(993 to 1527)
1386
(764 to 2007)
Visit 29: 0-50% Number Analyzed 20 participants 19 participants 22 participants 3 participants
83.1
(-62.7 to 229)
17.2
(-0.0182 to 34.4)
32.2
(-2.92 to 67.3)
30.0
(-99.1 to 159)
Visit 29: 50-60% Number Analyzed 20 participants 19 participants 22 participants 3 participants
25.3
(-7.86 to 58.5)
32.9
(4.18 to 61.7)
43.0
(13.9 to 72.1)
54.7
(-157 to 267)
Visit 29: 60-70% Number Analyzed 20 participants 19 participants 22 participants 3 participants
120
(42.8 to 197)
236
(96.3 to 375)
259
(65.8 to 453)
130
(-277 to 538)
Visit 29: 70-80% Number Analyzed 20 participants 19 participants 22 participants 3 participants
731
(524 to 938)
887
(690 to 1084)
732
(544 to 920)
855
(107 to 1604)
Visit 29: >80% Number Analyzed 20 participants 19 participants 22 participants 3 participants
1411
(1119 to 1704)
1201
(933 to 1468)
1293
(1032 to 1554)
1286
(212 to 2360)
Visit 41: 0-50% Number Analyzed 18 participants 17 participants 20 participants 3 participants
11.1
(2.12 to 20.0)
22.6
(-4.70 to 50.0)
6.60
(1.12 to 12.1)
1.33
(-4.40 to 7.07)
Visit 41: 50-60% Number Analyzed 18 participants 17 participants 20 participants 3 participants
12.3
(4.77 to 19.9)
34.0
(3.49 to 64.5)
25.5
(11.2 to 39.8)
5.33
(-17.6 to 28.3)
Visit 41: 60-70% Number Analyzed 18 participants 17 participants 20 participants 3 participants
99.3
(51.0 to 148)
308
(59.1 to 557)
171
(84.6 to 257)
271
(-685 to 1226)
Visit 41: 70-80% Number Analyzed 18 participants 17 participants 20 participants 3 participants
871
(609 to 1133)
825
(607 to 1043)
877
(621 to 1133)
1032
(-86.6 to 2151)
Visit 41: >80% Number Analyzed 18 participants 17 participants 20 participants 3 participants
1377
(1066 to 1689)
1185
(842 to 1528)
1293
(968 to 1617)
1091
(-999 to 3181)
9.Primary Outcome
Title Hemoglobin Mass
Hide Description To measure Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.
Time Frame Measured at Baseline (V3) and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: g
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 21 participants 4 participants
861
(747 to 975)
796
(701 to 891)
905
(808 to 1003)
883
(755 to 1012)
766
(290 to 1241)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
1194
(1001 to 1387)
1176
(1005 to 1347)
1224
(957 to 1490)
1217
(966 to 1468)
900
(454 to 1345)
10.Primary Outcome
Title Red Blood Cell Volume
Hide Description To measure Red blood cell volume (mL), measured with the carbon monoxide-rebreathing method.
Time Frame Measured at Baseline (V3) and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 21 participants 4 participants
2541
(2207 to 2875)
2353
(2076 to 2629)
2681
(2388 to 2975)
2605
(2231 to 2979)
2269
(871 to 3667)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
3523
(2959 to 4086)
3478
(2988 to 3967)
3618
(2838 to 4398)
3605
(2900 to 4309)
2623
(1357 to 3890)
11.Primary Outcome
Title Plasma Volume
Hide Description To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.
Time Frame Measured at Baseline (V3) and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 21 participants 4 participants
3429
(3044 to 3814)
3156
(2811 to 3500)
3558
(3242 to 3874)
3521
(3075 to 3966)
3252
(1558 to 4946)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
4840
(4139 to 5542)
4938
(4306 to 5570)
4959
(4190 to 5729)
5281
(4317 to 6245)
4272
(2238 to 6307)
12.Primary Outcome
Title Total Blood Volume
Hide Description To measure total blood volume (mL), measured with the carbon monoxide-rebreathing method.
Time Frame Measured at Baseline (V3) and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 21 participants 4 participants
5970
(5282 to 6657)
5508
(4914 to 6102)
6239
(5709 to 6770)
6126
(5326 to 6925)
5521
(2443 to 8599)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
8363
(7151 to 9575)
8416
(7334 to 9498)
8577
(7060 to 10095)
8886
(7263 to 10508)
6896
(3618 to 10173)
13.Primary Outcome
Title Capillary Blood Lactate Levels
Hide Description To measure changes from baseline of Capillary blood lactate levels (mmol/L), measured (with a portable lactate analyzer) during VO2max test.
Time Frame Measured at Baseline and week 15.
Outcome Measure Data Not Reported
14.Primary Outcome
Title Ventilation at VO2 Max
Hide Description To measure ventilation (L/min) at VO2max.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: L/min
Baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
74.8
(66.1 to 83.4)
78.9
(70.4 to 87.4)
87.3
(74.1 to 101)
71.9
(65.9 to 77.8)
109 55.7
77.2
(64.8 to 89.6)
Acute Effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
72.0
(66.1 to 77.9)
79.1
(70.4 to 87.9)
81.3
(67.4 to 95.1)
77.2
(69.0 to 85.5)
110 78.6
76.1
(63.2 to 89.0)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
72.7
(64.8 to 80.6)
79.2
(69.8 to 88.6)
82.5
(67.7 to 97.4)
80.3
(73.6 to 87.1)
72.0
(53.8 to 90.3)
15.Primary Outcome
Title Respiratory Rate
Hide Description To measure respiratory rate (breaths per minute) at VO2max.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: breaths/minute
Acute Baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
34.5
(31.3 to 37.7)
37.5
(33.4 to 41.5)
37.1
(30.7 to 43.4)
35.2
(32.1 to 38.2)
36.0 29.0
35.6
(32.3 to 39.0)
Acute Effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
34.1
(30.4 to 37.7)
37.8
(33.4 to 42.3)
35.4
(32.0 to 38.8)
36.1
(32.8 to 39.3)
38.0 37.0
34.1
(30.0 to 38.2)
Training Effect (V43 Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
33.8
(30.4 to 37.2)
37.0
(32.9 to 41.1)
33.8
(30.4 to 37.3)
36.3
(33.2 to 39.4)
38.4
(29.7 to 47.1)
16.Primary Outcome
Title VCO2
Hide Description To measure VCO2 (L/min) at VO2 max.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: L/min
Acute Baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
2.21
(2.01 to 2.42)
2.36
(2.07 to 2.65)
2.58
(2.14 to 3.02)
2.24
(2.00 to 2.49)
3.23 1.70
2.39
(1.98 to 2.80)
Acute Effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
2.19
(2.01 to 2.36)
2.41
(2.13 to 2.70)
2.53
(2.04 to 3.02)
2.41
(2.08 to 2.73)
3.28 2.10
2.38
(1.98 to 2.78)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
2.36
(2.12 to 2.59)
2.53
(2.16 to 2.90)
2.53
(2.01 to 3.05)
2.67
(2.35 to 2.99)
2.63
(1.96 to 3.29)
17.Primary Outcome
Title Respiratory Exchange Ratio
Hide Description To measure the respiratory exchange ratio (VCO2/VO2) at VO2max
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: ratio
Acute baseline (V3) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
1.18
(1.14 to 1.22)
1.16
(1.12 to 1.20)
1.19
(1.14 to 1.23)
1.16
(1.12 to 1.20)
1.17 1.05
1.14
(1.05 to 1.23)
Acute effect (V4) Number Analyzed 20 participants 17 participants 13 participants 20 participants 1 participants 1 participants 8 participants
1.20
(1.15 to 1.25)
1.17
(1.13 to 1.22)
1.18
(1.15 to 1.21)
1.17
(1.12 to 1.21)
1.18 1.19
1.14
(1.06 to 1.21)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 0 participants 0 participants 5 participants
1.16
(1.11 to 1.21)
1.16
(1.12 to 1.20)
1.18
(1.14 to 1.22)
1.18
(1.14 to 1.22)
1.21
(1.14 to 1.27)
18.Primary Outcome
Title Rating of Perceived Capacity by Sex
Hide Description To measure Rating of Perceived Capacity (RPC), determined by using the RPC scale. The RPC scale is a list of physical activities arranged in order, with a scale of values from least strenuous (1) to most exhausting (18 for women, 20 for men). Subjects choose the most strenuous activity, with corresponding value, which they could sustain for 30 minutes.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Dual-1 Dual-2 Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 1 1 8
Mean (95% Confidence Interval)
Unit of Measure: Rating of Perceived Capacity
Acute Baseline - Female (V3) Number Analyzed 13 participants 9 participants 6 participants 10 participants 0 participants 1 participants 4 participants
7.77
(5.75 to 9.79)
8.22
(6.56 to 9.89)
8.17
(5.83 to 10.5)
8.00
(7.11 to 8.89)
5.00
8.50
(4.50 to 12.5)
Acute Effect - Female (V4) Number Analyzed 13 participants 9 participants 6 participants 10 participants 0 participants 1 participants 4 participants
7.15
(6.46 to 7.84)
7.22
(5.31 to 9.14)
7.83
(7.40 to 8.26)
7.90
(6.34 to 9.46)
5.00
8.50
(4.50 to 12.5)
Acute Baseline - Male (V3) Number Analyzed 7 participants 8 participants 7 participants 10 participants 1 participants 0 participants 4 participants
8.00
(6.49 to 9.51)
8.25
(7.28 to 9.22)
9.71
(7.06 to 12.4)
9.70
(7.85 to 11.5)
8.00
7.00
(4.09 to 9.91)
Acute Effect - Male (V4) Number Analyzed 7 participants 8 participants 7 participants 10 participants 1 participants 0 participants 4 participants
6.86
(5.73 to 7.98)
9.13
(7.68 to 10.6)
10.7
(8.53 to 12.9)
9.90
(8.53 to 11.3)
9.00
6.25
(3.86 to 8.64)
Training Baseline - Female (V3) Number Analyzed 12 participants 9 participants 6 participants 11 participants 0 participants 0 participants 5 participants
6.92
(6.04 to 7.79)
8.22
(6.56 to 9.89)
7.67
(4.96 to 10.4)
8.00
(7.21 to 8.79)
10.4
(4.47 to 16.3)
Training Effect - Female (V43) Number Analyzed 12 participants 9 participants 5 participants 11 participants 0 participants 0 participants 5 participants
8.58
(7.27 to 9.90)
9.11
(7.55 to 10.7)
8.60
(6.18 to 11.0)
8.91
(7.49 to 10.3)
9.60
(5.81 to 13.4)
Training Baseline - Male (V3) Number Analyzed 9 participants 10 participants 7 participants 11 participants 0 participants 0 participants 0 participants
7.67
(6.34 to 9.00)
8.30
(7.54 to 9.06)
9.71
(7.06 to 12.4)
9.36
(7.55 to 11.2)
Training Effect - Male (V43) Number Analyzed 9 participants 10 participants 7 participants 10 participants 0 participants 0 participants 0 participants
8.33
(6.26 to 10.4)
10.1
(8.69 to 11.5)
9.14
(7.34 to 10.9)
11.8
(9.24 to 14.4)
19.Primary Outcome
Title Rating of Perceived Exertion
Hide Description To measure changes from baseline of the Rating of Perceived Exertion, determined by using the Borg scale. The Borg RPE scale is a numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." Subjects choose a number from the scale that best describes their level of exertion during a physical activity.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Outcome Measure Data Not Reported
20.Primary Outcome
Title Heart Rate
Hide Description To measure changes from baseline of heart rate (bpm) during VO2max test.
Time Frame Measured at Baseline, at week 1, and at week 15.
Outcome Measure Data Not Reported
21.Primary Outcome
Title Oxygen Uptake
Hide Description To measure changes from baseline of Oxygen uptake during VO2max test. (mL/min)
Time Frame Measured at Baseline, at week 1, and at week 15.
Outcome Measure Data Not Reported
22.Primary Outcome
Title High Density Lipoprotein (HDL)
Hide Description To measure HDL concentrations in serum (mg/dL).
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
49.3
(44.9 to 53.7)
48.2
(40.3 to 56.0)
47.1
(39.7 to 54.6)
52.1
(45.6 to 58.7)
55.4
(48.0 to 62.7)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
48.6
(43.8 to 53.4)
53.3
(45.5 to 61.1)
51.0
(41.5 to 60.4)
53.6
(47.4 to 59.7)
54.7
(47.5 to 61.9)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
51.0
(47.5 to 54.4)
49.0
(41.1 to 57.0)
51.8
(43.6 to 60.1)
53.3
(45.9 to 60.7)
56.2
(47.2 to 65.2)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
47.8
(43.2 to 52.4)
48.7
(41.2 to 56.2)
50.1
(40.8 to 59.5)
55.6
(49.6 to 61.7)
49.1
(44.0 to 54.2)
23.Primary Outcome
Title Low Density Lipoprotein (LDL)
Hide Description To measure LDL concentrations in serum (mg/dL).
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
124
(107 to 141)
111
(102 to 121)
122
(109 to 136)
115
(97.9 to 133)
155
(101 to 208)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
127
(112 to 142)
108
(98.8 to 118)
126
(106 to 145)
104
(87.3 to 121)
136
(79.4 to 193)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
131
(115 to 148)
105
(94.4 to 116)
122
(105 to 138)
106
(90.0 to 122)
140
(104 to 176)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
133
(111 to 155)
105
(91.6 to 118)
118
(101 to 135)
109
(90.5 to 127)
123
(81.5 to 164)
24.Primary Outcome
Title Very Low Density Lipoprotein (VLDL)
Hide Description To measure VLDL concentrations in serum (mg/dL).
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
14.7
(9.05 to 20.4)
13.7
(8.29 to 19.1)
15.8
(10.2 to 21.4)
13.7
(8.45 to 18.9)
12.5
(-1.89 to 26.9)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
15.6
(5.38 to 25.8)
8.30
(5.42 to 11.2)
11.1
(5.63 to 16.6)
11.4
(6.64 to 16.1)
9.82
(4.76 to 14.9)
Week 10 (V28) Number Analyzed 20 participants 18 participants 11 participants 21 participants 5 participants
14.7
(9.06 to 20.4)
13.7
(0.242 to 27.1)
12.0
(6.79 to 17.1)
6.56
(4.86 to 8.25)
10.3
(5.21 to 15.4)
Week 12 (V43) Number Analyzed 18 participants 17 participants 12 participants 18 participants 5 participants
10.7
(7.41 to 13.9)
12.4
(5.34 to 19.5)
12.1
(6.31 to 18.0)
12.3
(4.87 to 19.8)
10.8
(5.91 to 15.6)
25.Primary Outcome
Title High Sensitivity C-reactive Protein (Hs-CRP)
Hide Description To measure hs-CRP concentrations in serum (mg/dL).
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mg/L
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
2.10
(0.590 to 3.62)
2.19
(0.983 to 3.40)
0.804
(0.432 to 1.18)
1.80
(0.964 to 2.63)
1.17
(-0.754 to 3.09)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
1.40
(0.805 to 2.00)
1.84
(0.845 to 2.83)
1.24
(0.644 to 1.83)
1.43
(0.833 to 2.03)
1.37
(-0.729 to 3.47)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
1.67
(1.11 to 2.23)
2.57
(1.06 to 4.07)
0.815
(0.438 to 1.19)
2.38
(0.659 to 4.10)
1.43
(-0.947 to 3.81)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
1.55
(0.624 to 2.47)
2.79
(0.399 to 5.19)
1.69
(0.205 to 3.17)
1.61
(0.745 to 2.48)
1.26
(-1.08 to 3.60)
26.Primary Outcome
Title Growth Hormone
Hide Description To measure growth hormone concentrations in serum (ng/mL).
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
2.15
(0.726 to 3.58)
1.37
(0.594 to 2.15)
2.49
(0.0590 to 4.93)
4.03
(0.381 to 7.67)
2.02
(-1.36 to 5.41)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
1.25
(0.452 to 2.06)
1.49
(0.535 to 2.44)
1.22
(0.333 to 2.10)
1.30
(0.444 to 2.16)
1.13
(-1.24 to 3.50)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
1.45
(0.689 to 2.22)
0.907
(0.394 to 1.42)
1.31
(0.453 to 2.17)
1.97
(0.729 to 3.21)
0.536
(0.0523 to 1.02)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
1.98
(0.487 to 3.47)
1.44
(0.391 to 2.50)
1.94
(0.175 to 3.70)
1.55
(0.582 to 2.51)
0.492
(0.0520 to 0.932)
27.Primary Outcome
Title Hemoglobin A1c (HbA1c)
Hide Description To measure glycosylated hemoglobin (HbA1c in whole blood).
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: % (of red blood cells)
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
5.44
(5.34 to 5.53)
5.39
(5.27 to 5.51)
5.38
(5.22 to 5.53)
5.53
(5.37 to 5.68)
5.36
(4.91 to 5.81)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
5.41
(5.30 to 5.52)
5.35
(5.21 to 5.49)
5.41
(5.23 to 5.58)
5.50
(5.34 to 5.66)
5.28
(4.90 to 5.66)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
5.38
(5.27 to 5.49)
5.34
(5.22 to 5.46)
5.38
(5.18 to 5.57)
5.49
(5.32 to 5.65)
5.28
(5.00 to 5.56)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
5.40
(5.30 to 5.49)
5.35
(5.22 to 5.47)
5.34
(5.17 to 5.51)
5.50
(5.34 to 5.66)
5.34
(4.94 to 5.74)
28.Primary Outcome
Title Resting Systolic Blood Pressure
Hide Description To measure resting systolic blood pressure in mmHg.
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: mmHg
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
118
(113 to 123)
121
(116 to 127)
118
(110 to 126)
122
(116 to 129)
108
(101 to 114)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
117
(113 to 122)
124
(118 to 130)
120
(113 to 128)
122
(116 to 128)
111
(94.0 to 129)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
117
(111 to 122)
121
(113 to 128)
113
(107 to 119)
124
(117 to 131)
110
(101 to 119)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
116
(112 to 121)
119
(112 to 126)
116
(108 to 124)
122
(115 to 129)
109
(101 to 117)
29.Primary Outcome
Title Resting Pulse Rate
Hide Description To measure resting heart rate in bpm.
Time Frame Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: beats/minute
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
68.8
(64.5 to 73.2)
68.2
(63.8 to 72.5)
67.9
(61.8 to 74.0)
65.8
(61.0 to 70.5)
73.8
(60.3 to 87.3)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
65.1
(62.5 to 67.7)
60.0
(56.5 to 63.5)
63.3
(58.9 to 67.7)
60.1
(56.3 to 63.9)
62.2
(51.4 to 73.0)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
65.1
(62.1 to 68.2)
60.3
(56.4 to 64.3)
60.7
(54.6 to 66.8)
59.9
(56.0 to 63.8)
65.4
(50.8 to 80.0)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
70.5
(65.6 to 75.3)
65.8
(61.4 to 70.2)
69.5
(63.7 to 75.3)
63.9
(59.2 to 68.6)
73.2
(55.2 to 91.2)
30.Primary Outcome
Title Body Fat
Hide Description To measure body fat as a percentage.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: % (body fat)
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
27.8
(24.8 to 30.8)
28.2
(24.6 to 31.8)
25.6
(20.9 to 30.2)
27.3
(23.2 to 31.5)
20.5
(14.2 to 26.8)
Acute Effect (V4) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
28.1
(25.3 to 30.9)
28.6
(24.7 to 32.6)
25.4
(19.6 to 31.2)
28.1
(24.5 to 31.7)
28
(20.7 to 35.3)
Training Effect (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
30.6
(27.5 to 33.7)
27.5
(24.3 to 30.8)
28
(23 to 33)
29.9
(25.9 to 34)
30.1
(23.1 to 37.2)
31.Primary Outcome
Title Waist Circumference
Hide Description To measure waist circumference in cm.
Time Frame Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: cm
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
82.6
(77.9 to 87.3)
83.7
(79 to 88.5)
84.4
(80 to 88.8)
84.9
(80.3 to 89.5)
78.4
(63.5 to 93.3)
Acute Effect (V4) Number Analyzed 17 participants 14 participants 12 participants 19 participants 5 participants
82.1
(76.6 to 87.5)
81.6
(76.8 to 86.4)
83.6
(77.7 to 89.5)
85.2
(80.4 to 90.1)
77.6
(63.5 to 91.7)
Training Effect (V43) Number Analyzed 18 participants 14 participants 8 participants 17 participants 3 participants
85.8
(80.5 to 91.1)
86.6
(80.2 to 93.1)
87.3
(78.3 to 96.2)
89.5
(84.1 to 94.9)
86
(54.9 to 117)
32.Primary Outcome
Title Body Weight
Hide Description To measure body weight in kilograms.
Time Frame Measured at each visit, starting from Baseline (V3) until week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: kg
Baseline (V3)
72
(66.9 to 77.1)
75.7
(69.7 to 81.7)
75.5
(68.7 to 82.3)
77.5
(72.2 to 82.8)
69.3
(57.4 to 81.2)
Acute Effect (V4)
72.2
(67 to 77.4)
75.7
(69.7 to 81.6)
75.5
(68.5 to 82.4)
77.6
(72.2 to 83)
69.6
(57.5 to 81.7)
Month 1 (V5 - V13)
72
(66.9 to 77)
75.7
(69.8 to 81.6)
75.7
(69 to 82.5)
77.9
(72.4 to 83.3)
69.8
(57.3 to 82.2)
Month 2 (V14 - V27)
72
(67.1 to 76.8)
75.8
(69.7 to 81.9)
76.1
(69.4 to 82.9)
78.1
(72.6 to 83.6)
70.2
(57.2 to 83.1)
Month 3 (V28 - V43)
72
(67.1 to 76.8)
75.8
(69.7 to 81.9)
76.6
(69.6 to 83.5)
78.3
(72.8 to 83.8)
70.5
(57.8 to 83.2)
33.Primary Outcome
Title Exhaled Carbon Monoxide
Hide Description To measure exhaled carbon monoxide (ppm).
Time Frame Measured at each visit, starting from Baseline (V3) until week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: ppm
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
20.8
(17.3 to 24.3)
20.8
(16.6 to 25.0)
19.7
(14.8 to 24.6)
18.6
(14.7 to 22.6)
20.4
(7.30 to 33.5)
Week 1 (V4) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
25.4
(20.7 to 30.1)
6.16
(2.44 to 9.87)
5.46
(2.36 to 8.56)
3.55
(2.53 to 4.56)
4.80
(-0.274 to 9.87)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
20.6
(15.3 to 25.9)
5.00
(2.84 to 7.16)
8.38
(-3.78 to 20.6)
2.77
(2.32 to 3.23)
2.60
(0.717 to 4.48)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
20.6
(16.3 to 24.9)
4.58
(2.69 to 6.47)
4.00
(2.60 to 5.40)
2.64
(2.05 to 3.23)
2.40
(0.984 to 3.82)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
21.8
(16.8 to 26.7)
5.79
(2.96 to 8.62)
3.17
(1.52 to 4.81)
3.05
(2.14 to 3.95)
2.00
(0.758 to 3.24)
34.Primary Outcome
Title Carboxyhemoglobin
Hide Description To measure Carboxyhemoglobin (COHb), assayed from whole blood. Expressed as % of saturation of hemoglobin.
Time Frame Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: % (of saturation of hemoglobin)
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
1.92
(1.43 to 2.58)
2.37
(1.82 to 3.09)
1.71
(1.31 to 2.23)
1.74
(1.10 to 2.74)
2.50
(1.10 to 5.69)
Week 1 (V4) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
3.29
(2.61 to 4.16)
0.422
(0.231 to 0.773)
0.372
(0.151 to 0.915)
0.272
(0.163 to 0.456)
0.426
(0.172 to 1.06)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
2.51
(1.99 to 3.16)
0.350
(0.181 to 0.679)
0.109
(0.0509 to 0.234)
0.110
(0.0703 to 0.173)
0.272
(0.0778 to 0.954)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
3.01
(2.34 to 3.87)
0.338
(0.190 to 0.601)
0.285
(0.158 to 0.513)
0.189
(0.128 to 0.279)
0.432
(0.0520 to 3.58)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
2.04
(1.60 to 2.61)
0.187
(0.0868 to 0.402)
0.0674
(0.0395 to 0.115)
0.0864
(0.0557 to 0.134)
0.132
(0.0495 to 0.352)
35.Primary Outcome
Title NEQ
Hide Description To measure Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Time Frame Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/g creat
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
14.9
(11.7 to 19.0)
14.2
(11.5 to 17.5)
10.5
(7.55 to 14.5)
12.9
(10.1 to 16.3)
14.0
(6.14 to 32.1)
Week 1 (V4) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
13.2
(10.2 to 17.0)
10.9
(7.90 to 15.0)
7.08
(4.38 to 11.5)
4.40
(2.36 to 8.18)
8.49
(1.39 to 51.9)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
13.2
(10.2 to 17.0)
10.9
(7.90 to 15.0)
7.08
(4.38 to 11.5)
4.40
(2.36 to 8.18)
9.03
(1.19 to 68.6)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 21 participants 5 participants
14.3
(12.2 to 16.6)
11.4
(7.94 to 16.4)
8.66
(5.27 to 14.2)
1.59
(0.774 to 3.25)
11.6
(1.93 to 70.2)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
13.8
(11.4 to 16.8)
12.3
(9.69 to 15.7)
5.93
(3.86 to 9.11)
2.70
(1.49 to 4.90)
5.87
(1.28 to 27.0)
36.Primary Outcome
Title Total NNAL
Hide Description To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Time Frame Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
170
(99.3 to 291)
239
(184 to 310)
164
(87.5 to 307)
166
(114 to 243)
244
(73.3 to 813)
Week 1 (V4) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
147
(84.5 to 254)
88.3
(45.8 to 170)
69.9
(31.9 to 153)
45.8
(30.6 to 68.5)
97.9
(38.0 to 252)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
177
(113 to 278)
90.2
(62.6 to 130)
62.7
(31.8 to 123)
17.4
(9.53 to 31.9)
93.4
(30.7 to 284)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
221
(155 to 315)
81.3
(49.3 to 134)
74.6
(32.4 to 171)
26.1
(12.1 to 56.4)
83.3
(14.1 to 490)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
214
(163 to 280)
82.5
(46.1 to 148)
37.9
(20.7 to 69.4)
41.3
(22.9 to 74.5)
62.3
(21.3 to 182)
37.Primary Outcome
Title CEMA
Hide Description To measure 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Time Frame Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mg creat
Baseline (V3) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
140
(106 to 185)
170
(143 to 202)
135
(97.1 to 188)
128
(95.9 to 172)
144
(57.3 to 362)
Week 1 (V4) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
147
(114 to 189)
39.5
(26.8 to 58.4)
28.1
(14.6 to 53.9)
25.3
(18.3 to 34.9)
37.5
(12.9 to 109)
Week 6 (V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
139
(104 to 185)
26.6
(15.8 to 44.8)
15.3
(7.89 to 29.8)
12.1
(8.47 to 17.2)
33.1
(6.10 to 180)
Week 10 (V28) Number Analyzed 21 participants 19 participants 13 participants 22 participants 5 participants
148
(113 to 194)
23.6
(14.4 to 38.7)
12.7
(5.99 to 26.9)
11.0
(7.58 to 15.9)
19.3
(4.88 to 76.0)
Week 12 (V43) Number Analyzed 21 participants 19 participants 12 participants 21 participants 5 participants
141
(108 to 183)
24.8
(12.4 to 49.4)
8.67
(4.05 to 18.6)
12.7
(7.50 to 21.3)
16.5
(3.90 to 69.7)
38.Primary Outcome
Title Nicotine/Tobacco Product Use (Cigarettes)
Hide Description To measure self-reported number of any nicotine/tobacco product used on a daily basis.
Time Frame Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: cigarettes per day
Pre-randomization (V2-V3) Number Analyzed 17 participants 18 participants 12 participants 22 participants 3 participants
16.8
(13.9 to 19.7)
19.0
(16.4 to 21.5)
17.4
(14.3 to 20.4)
17.7
(14.7 to 20.8)
24.1
(18.9 to 29.4)
Week 1 (V3-V4) Number Analyzed 19 participants 19 participants 13 participants 21 participants 3 participants
17.5
(15.0 to 20.0)
0.206
(0 to 0.439)
0.242
(0 to 0.556)
0.0136
(0 to 0.0420)
9.72
(0 to 41.4)
Up to month 1 (V3-V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
17.3
(15.2 to 19.5)
0.0351
(0 to 0.0753)
0.0623
(0 to 0.132)
0.00222
(0 to 0.00683)
8.86
(0 to 25.0)
Up to month 2 (V3-V26 Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
17.1
(14.8 to 19.4)
0.0196
(0 to 0.0413)
0.0369
(0 to 0.0783)
0.00132
(0 to 0.00406)
8.38
(0 to 24.3)
Overall (V3-V43) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
17.1
(14.7 to 19.5)
0.0142
(0.000387 to 0.0280)
0.0273
(0 to 0.0592)
0.000858
(0 to 0.00264)
8.34
(0 to 24.3)
39.Primary Outcome
Title Nicotine/Tobacco Product Use (HeatSticks)
Hide Description To measure self-reported number of any nicotine/tobacco product used on a daily basis.
Time Frame Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: heatsticks per day
Pre-randomization (V2-V3) Number Analyzed 17 participants 18 participants 12 participants 22 participants 3 participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Week 1 (V3-V4) Number Analyzed 19 participants 19 participants 13 participants 21 participants 3 participants
0
(0 to 0)
17.7
(13.3 to 22.1)
14.1
(10.5 to 17.7)
0
(0 to 0)
5.81
(0 to 30.8)
Up to month 1 (V3-V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
0
(0 to 0)
18.6
(14.4 to 22.9)
14.0
(10.8 to 17.1)
0
(0 to 0)
4.97
(0 to 20.8)
Up to month 2 (V3-V26 Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
0
(0 to 0)
18.7
(14.5 to 22.9)
14.1
(10.9 to 17.4)
0
(0 to 0)
4.97
(0 to 20.8)
Overall (V3-V43) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
0
(0 to 0)
19.0
(14.6 to 23.3)
14.1
(10.9 to 17.2)
0
(0 to 0)
5.08
(0 to 21.3)
40.Primary Outcome
Title Nicotine/Tobacco Product Use (E-cigarettes)
Hide Description To measure self-reported number of any nicotine/tobacco product used on a daily basis.
Time Frame Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description:

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
Overall Number of Participants Analyzed 21 19 13 22 5
Mean (95% Confidence Interval)
Unit of Measure: e-cigarettes per day
Pre-randomization (V2-V3) Number Analyzed 17 participants 18 participants 12 participants 22 participants 3 participants
0
(0 to 0)
0
(0 to 0)
0.0952
(0 to 0.305)
0
(0 to 0)
0
(0 to 0)
Week 1 (V3-V4) Number Analyzed 19 participants 19 participants 13 participants 21 participants 3 participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Up to month 1 (V3-V14) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Up to month 2 (V3-V26 Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Overall (V3-V43) Number Analyzed 21 participants 19 participants 13 participants 22 participants 4 participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Time Frame Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 24 weeks for each subject.
Adverse Event Reporting Description The safety set comprised the 93 subjects enrolled in the study. Adverse events are reported according to the study arm (Cigarette; IQOS-1; IQOS-2; and Smoking Abstinence) that each subject was randomized to.
 
Arm/Group Title Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Hide Arm/Group Description

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program

IQOS without Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program

Other product use (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
All-Cause Mortality
Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/22 (0.00%)      0/13 (0.00%)      0/24 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      1/13 (7.69%)      1/24 (4.17%)      0/12 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Adenocarcinoma of colon * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 1/24 (4.17%)  1 0/12 (0.00%)  0
Uterine leiomyoma * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0
Reproductive system and breast disorders           
Ovarian cyst * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0
1
Term from vocabulary, MeDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cigarette Smoking IQOS-1 IQOS-2 Smoking Abstinence Other
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/22 (54.55%)      10/22 (45.45%)      8/13 (61.54%)      12/24 (50.00%)      5/12 (41.67%)    
Gastrointestinal disorders           
Gingival bleeding * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/13 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0
Nausea * 1  0/22 (0.00%)  0 2/22 (9.09%)  2 0/13 (0.00%)  0 0/24 (0.00%)  0 1/12 (8.33%)  2
Vomiting * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/13 (0.00%)  0 0/24 (0.00%)  0 1/12 (8.33%)  1
Dental caries * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations           
Nasopharyngitis * 1  8/22 (36.36%)  8 3/22 (13.64%)  3 3/13 (23.08%)  3 3/24 (12.50%)  3 3/12 (25.00%)  3
Gastroenteritis * 1  0/22 (0.00%)  0 2/22 (9.09%)  2 0/13 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal infection * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications           
Procedural pain * 1  0/22 (0.00%)  0 2/22 (9.09%)  2 2/13 (15.38%)  2 1/24 (4.17%)  1 0/12 (0.00%)  0
Investigations           
Blood Tryglycerides Increased * 1  1/22 (4.55%)  1 1/22 (4.55%)  1 1/13 (7.69%)  1 2/24 (8.33%)  2 0/12 (0.00%)  0
Gamma-glutamyltransferase increased * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 1/24 (4.17%)  1 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders           
Back pain * 1  3/22 (13.64%)  3 2/22 (9.09%)  2 0/13 (0.00%)  0 1/24 (4.17%)  1 1/12 (8.33%)  1
Arthralgia * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/13 (0.00%)  0 2/24 (8.33%)  2 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Uterine leiomyoma * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders           
Headache * 1  1/22 (4.55%)  2 0/22 (0.00%)  0 1/13 (7.69%)  1 4/24 (16.67%)  4 1/12 (8.33%)  1
Reproductive system and breast disorders           
Ovarian cyst * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough * 1  3/22 (13.64%)  3 1/22 (4.55%)  1 0/13 (0.00%)  0 1/24 (4.17%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders           
Angioedema * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 0/24 (0.00%)  0 1/12 (8.33%)  1
Urticaria * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 0/24 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, MeDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.

The Intellectual Property rights and research results from the present study belong to the Sponsor.

Results Point of Contact
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Name/Title: Christelle Haziza, Global Head Clinical Research and Execution
Organization: Philip Morris Products S.A.
Phone: +41 58 242 11 11
EMail: ClinicalTrials.PMI@pmi.com
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03887117    
Other Study ID Numbers: P1-EXC-01-EU
First Submitted: February 28, 2019
First Posted: March 22, 2019
Results First Submitted: September 10, 2021
Results First Posted: December 27, 2021
Last Update Posted: December 27, 2021