Trial Outcomes & Findings for The END Perioperative Smoking Pilot Study (NCT NCT02482233)
NCT ID: NCT02482233
Last Updated: 2022-03-09
Results Overview
Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide \<10ppm. Time Frame depends on date of preadmission clinic visit
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
day of surgery (expected average around 1-2 weeks after enrollment/randomization)
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
Nicotine Replacement Patch Group (Control)
Patients randomized to the NRT group received a 6-week supply of NicodermCQ patches (5 weeks) and placebo patches (1 week) appropriate to baseline nicotine consumption.
|
Electronic Cigarette (END) Group
Those allocated to the END group received a 6-week supply of NJOY e-cigarettes (Scottsdale, AZ, USA) and were instructed to use the Bold (4.5%) e-cigarettes ad libitum for 3 weeks, the Gold (2.4%) e-cigarettes ad libitum for 2 weeks and the Study (0%) ecigarettes ad libitum for the final week.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
20
|
|
Overall Study
COMPLETED
|
9
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Nicotine Replacement Patch Group (Control)
Patients randomized to the NRT group received a 6-week supply of NicodermCQ patches (5 weeks) and placebo patches (1 week) appropriate to baseline nicotine consumption.
|
Electronic Cigarette (END) Group
Those allocated to the END group received a 6-week supply of NJOY e-cigarettes (Scottsdale, AZ, USA) and were instructed to use the Bold (4.5%) e-cigarettes ad libitum for 3 weeks, the Gold (2.4%) e-cigarettes ad libitum for 2 weeks and the Study (0%) ecigarettes ad libitum for the final week.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The END Perioperative Smoking Pilot Study
Baseline characteristics by cohort
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As described above
|
Electronic Cigarette (END)
n=20 Participants
As described above
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
54 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
54 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Day seen prior to surgery
|
16.5 days
STANDARD_DEVIATION 9.5 • n=5 Participants
|
11.2 days
STANDARD_DEVIATION 7.9 • n=7 Participants
|
13.0 days
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Diabetes
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Hypertension
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Heart disease
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
COPD
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cigarettes smoked per day
|
10.8 cigarettes
STANDARD_DEVIATION 6.6 • n=5 Participants
|
15.3 cigarettes
STANDARD_DEVIATION 10.5 • n=7 Participants
|
13.8 cigarettes
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Number of years smoking
|
32 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
32 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
32 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Fagerstrom score
|
2.5 units on a scale out of 10 min 1 max 10
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.7 units on a scale out of 10 min 1 max 10
STANDARD_DEVIATION 2.6 • n=7 Participants
|
3.3 units on a scale out of 10 min 1 max 10
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Salivary cotinine (ng/ml)
|
130.1 ng/ml
STANDARD_DEVIATION 75.3 • n=5 Participants
|
209.6 ng/ml
STANDARD_DEVIATION 110.3 • n=7 Participants
|
183.1 ng/ml
STANDARD_DEVIATION 98.6 • n=5 Participants
|
|
Exhaled CO (ppm)
|
16.1 ppm
STANDARD_DEVIATION 7.7 • n=5 Participants
|
21.7 ppm
STANDARD_DEVIATION 11.5 • n=7 Participants
|
19.8 ppm
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
FEV1 (L)
|
3.14 L
STANDARD_DEVIATION 1.35 • n=5 Participants
|
2.78 L
STANDARD_DEVIATION 1.11 • n=7 Participants
|
2.9 L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
FVC (L)
|
3.52 L
STANDARD_DEVIATION 1.28 • n=5 Participants
|
4.03 L
STANDARD_DEVIATION 1.32 • n=7 Participants
|
3.9 L
STANDARD_DEVIATION 1.31 • n=5 Participants
|
|
FEV1/FVC (%)
|
105 percent
STANDARD_DEVIATION 81.3 • n=5 Participants
|
68.2 percent
STANDARD_DEVIATION 13.0 • n=7 Participants
|
80.5 percent
STANDARD_DEVIATION 35.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: day of surgery (expected average around 1-2 weeks after enrollment/randomization)Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide \<10ppm. Time Frame depends on date of preadmission clinic visit
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=20 Participants
As above
|
|---|---|---|
|
Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8-weeksPopulation: in-person visit at 8-weeks, or make-up phone call if unavailable in-person
how often product (e-cigarette or patch) was used (everyday except while hospitalized, most days, a few times a week, once a week, less than once a week, not at all) Result reported is those that used the product daily or most days
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
Frequency of Use of Product - Number Reporting Use Daily or Most Days
|
6 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 8-weeks7-point likert scale (strongly disagree to strongly agree) 1. strongly disagree 2. disagree 3. disagree somewhat 4. neither agree nor disagree 5. agree somewhat 6. agree 7. strongly agree
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
Report of How Helpful the Product Was for Quitting
|
5 units on a scale out of 7
Interval 3.0 to 7.0
|
6 units on a scale out of 7
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: 8-weeks7-point likert scale (strongly disagree to strongly agree) 1. strongly disagree 2. disagree 3. disagree somewhat 4. neither agree nor disagree 5. agree somewhat 6. agree 7. strongly agree
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
How Satisfied the Patient Was With the Product (E-cigarette or Patch)
|
5 units on a scale out of 7
Interval 3.0 to 6.0
|
5.5 units on a scale out of 7
Interval 2.5 to 7.0
|
SECONDARY outcome
Timeframe: 8-weeks7-point likert scale (strongly disagree to strongly agree) 1. strongly disagree 2. disagree 3. disagree somewhat 4. neither agree nor disagree 5. agree somewhat 6. agree 7. strongly agree
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others
|
7 units on a scale out of 7
Interval 6.0 to 7.0
|
6 units on a scale out of 7
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: 8-weeksPopulation: Those lost to follow-up assumed to still be smoking (1 in NRT group). Those who had telephone interview were unable to have exhaled CO verification (n=1 in NRT group, n=2 in END group). Since they were not verified by exhaled CO, they were not considered abstinent.
by self-report and confirmed by exhaled CO\<10ppm - confirmed abstinent
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=9 Participants
As above
|
Electronic Cigarette (END)
n=20 Participants
As above
|
|---|---|---|
|
Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: on day of surgery and 8-weeks after randomization50% or less regular cigarette use compared to baseline as determined by asking participants to self-report daily cigarette use in cigarettes per day at each time point.
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=20 Participants
As above
|
|---|---|---|
|
Smoking Reduction
|
7 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: on day of surgery and 8-weeks after randomizationuse of both regular and e-cigarettes concurrently
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=20 Participants
As above
|
|---|---|---|
|
Number of Participants With Dual Use
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: day of surgery and 8-weeksChange in FEV1/FVC from baseline to day of surgery / 8-weeks. FEV1/FVC is expressed in percent. For example, if FEV1/FVC was 75%, 80%, and 85% at baseline, day of surgery and 8-weeks, result is reported as change in FEV1/FVC being +5% and +10% for day of surgery and 8-weeks respectively.
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=18 Participants
As above
|
|---|---|---|
|
Spirometry - FEV1/FVC Change
FEV1/FVC on day of surgery compared to baseline
|
-32.2 percent (change from baseline)
Standard Deviation 74
|
-1.6 percent (change from baseline)
Standard Deviation 8.2
|
|
Spirometry - FEV1/FVC Change
FEV1/FVC at 8 weeks compared to baseline
|
-38.1 percent (change from baseline)
Standard Deviation 79.2
|
2.0 percent (change from baseline)
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: day of surgery and 8-weekschange in FEV1 (mL) compared to baseline
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=18 Participants
As above
|
|---|---|---|
|
Spirometry - FEV1
change in FEV1 day of surgery
|
-236 mL
Standard Deviation 585
|
-163 mL
Standard Deviation 549
|
|
Spirometry - FEV1
change in FEV1 8-weeks
|
-300 mL
Standard Deviation 497
|
292 mL
Standard Deviation 503
|
SECONDARY outcome
Timeframe: day of surgery and 8-weekssalivary
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=18 Participants
As above
|
|---|---|---|
|
Cotinine Level (Change in)
day of surgery
|
106 ng/ml
Standard Deviation 137
|
19 ng/ml
Standard Deviation 119
|
|
Cotinine Level (Change in)
8-weeks
|
34 ng/ml
Standard Deviation 89
|
-48 ng/ml
Standard Deviation 103
|
SECONDARY outcome
Timeframe: 30-days postopby chart review - research assistant or investigator examined notes and investigations postoperatively for complications by telephone self-report - patients were asked open-ended question about whether they experienced any postoperative complications
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
Number of Participants With Postoperative Complications (Composite)
by chart review
|
6 Participants
|
5 Participants
|
|
Number of Participants With Postoperative Complications (Composite)
by telephone self-report
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: those lost assumed to still be smoking
by self-report (7-day point prevalence)
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=9 Participants
As above
|
Electronic Cigarette (END)
n=20 Participants
As above
|
|---|---|---|
|
Long-term Smoking Status - Use of Conventional Cigarettes
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 8 weeksall patients will be asked about adverse events each time they are contacted (day of surgery, 30-days postoperatively, and 8-weeks after randomization), and they will also be able to call to report adverse events to the study team any time during the study.
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=9 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
any adverse event
|
3 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
moderate adverse event (required intervention)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30-days postopby telephone self-report
Outcome measures
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 Participants
As above
|
Electronic Cigarette (END)
n=19 Participants
As above
|
|---|---|---|
|
Number of Participants Postoperative Complications (Composite)
|
2 Participants
|
5 Participants
|
Adverse Events
Nicotine Replacement Therapy (NRT)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Electronic Cigarette (END)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Replacement Therapy (NRT)
n=10 participants at risk
As above
|
Electronic Cigarette (END)
n=20 participants at risk
As above
|
|---|---|---|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4
|
20.0%
4/20 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1
|
25.0%
5/20 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough (persistent)
|
0.00%
0/10
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough (intermittent)
|
10.0%
1/10 • Number of events 1
|
30.0%
6/20 • Number of events 6
|
|
Cardiac disorders
palpitations
|
20.0%
2/10 • Number of events 2
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
30.0%
3/10 • Number of events 3
|
25.0%
5/20 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
30.0%
3/10 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
General disorders
other
|
60.0%
6/10 • Number of events 6
|
35.0%
7/20 • Number of events 7
|
Additional Information
Dr. Susan Ming Lee
Royal Columbian Hospital / University of British Columbia
Phone: 604-520-4253
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place