Trial Outcomes & Findings for Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems (NCT NCT05423340)
NCT ID: NCT05423340
Last Updated: 2026-06-04
Results Overview
Oxidative stress and inflammation in plasma using ELISA.
COMPLETED
NA
163 participants
Up to around 90 days.
2026-06-04
Participant Flow
Recruitment started at June 12 2022, and completed at October 03 2024. Recruitments were performed by Roswell Park Cancer Institute, an comprehensive cancer center located at Buffalo NY, in collaboration of University of Rochester, National Institutes of Health (NIH) and National Cancer Institute (NCI).
There were 334 subjects responded to advertisement. Among them, 71 were deemed ineligble, and 100 were eligible but not interested, resulted in 163 protocol enrollment.
Participant milestones
| Measure |
Use Own Brand of Flavored Product
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
54
|
|
Overall Study
COMPLETED
|
47
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems
Baseline characteristics by cohort
| Measure |
Use Own Brand of Flavored Product
n=47 Participants
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
n=41 Participants
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
n=43 Participants
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.0 year
n=9 Participants
|
32.0 year
n=27 Participants
|
30.0 year
n=267 Participants
|
31.0 year
n=265 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
73 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
58 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
93 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
23 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Up to around 90 days.Population: A quantitative measure of expression (units:pg/mg) will be produced on Visit 1-beginning of the trial and Visit 4-after 3 months ± 14 days.
Oxidative stress and inflammation in plasma using ELISA.
Outcome measures
| Measure |
Use Own Brand of Flavored Product
n=47 Participants
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
n=41 Participants
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
n=43 Participants
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
|---|---|---|---|
|
Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
interleukin-6 (IL-6) Visit 4
|
2 pg/mL
Interval 1.6 to 2.3
|
1.8 pg/mL
Interval 1.6 to 2.2
|
1.9 pg/mL
Interval 1.5 to 2.0
|
|
Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
Interluekin-8(IL-8) Visit 1
|
0.56 pg/mL
Interval 0.33 to 0.65
|
0.67 pg/mL
Interval 0.35 to 0.74
|
0.64 pg/mL
Interval 0.53 to 0.72
|
|
Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
Interluekin-8(IL-8) Visit 4
|
0.58 pg/mL
Interval 0.53 to 0.64
|
0.59 pg/mL
Interval 0.52 to 0.86
|
0.57 pg/mL
Interval 0.5 to 0.74
|
|
Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
C-reactive Protein (CRP) Visit 1
|
7867.6 pg/mL
Interval 3710.1 to 15996.0
|
1348.8 pg/mL
Interval 762.5 to 5551.5
|
3151.9 pg/mL
Interval 1431.3 to 11728.7
|
|
Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
C-reactive Protein (CRP) Visit 4
|
6341.3 pg/mL
Interval 1135.2 to 9081.9
|
2051.3 pg/mL
Interval 1289.9 to 4640.3
|
3338.8 pg/mL
Interval 858.0 to 8005.3
|
|
Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
interleukin-6 (IL-6) Visit 1
|
0.8 pg/mL
Interval 0.4 to 1.0
|
0.6 pg/mL
Interval 0.5 to 1.2
|
0.7 pg/mL
Interval 0.4 to 0.9
|
PRIMARY outcome
Timeframe: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 daysPopulation: Measurements are taken on Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days.
Exhaled Nitric Oxide (FeNo)l be measured in participants' breath using a FDA cleared monitor NIOX VERO (Aerocrine) according to ATS guidelines. FeNO has been used to monitor airway inflammation to account for persistent and/or high allergen exposure as a factor associated with higher levels of FeNO
Outcome measures
| Measure |
Use Own Brand of Flavored Product
n=47 Participants
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
n=41 Participants
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
n=43 Participants
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
|---|---|---|---|
|
Respiratory Tract Inflammation Activity
Visit 1
|
10.0 ppb
Interval 6.0 to 16.0
|
8 ppb
Interval 5.0 to 12.0
|
11 ppb
Interval 8.0 to 17.0
|
|
Respiratory Tract Inflammation Activity
Visit 2
|
9.5 ppb
Interval 7.0 to 12.2
|
9 ppb
Interval 5.5 to 12.5
|
11.5 ppb
Interval 7.0 to 18.2
|
|
Respiratory Tract Inflammation Activity
Visit 3
|
10 ppb
Interval 7.8 to 13.2
|
8 ppb
Interval 6.0 to 12.0
|
12 ppb
Interval 6.0 to 18.5
|
|
Respiratory Tract Inflammation Activity
Visit 4
|
9 ppb
Interval 6.0 to 15.2
|
9 ppb
Interval 6.0 to 13.0
|
11.5 ppb
Interval 8.0 to 16.8
|
SECONDARY outcome
Timeframe: up to 90 daysAssessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use. Amount of recent flavored product use were assessed throughout the entire study and estimates per month. The average (with standard deviation) amount of volume (mL) of e-liquid purchased by participants throughout the entire study were reported.
Outcome measures
| Measure |
Use Own Brand of Flavored Product
n=47 Participants
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
n=41 Participants
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
n=43 Participants
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
|---|---|---|---|
|
Amount of Recent Flavored Product Use
|
199.7 mL
Standard Deviation 180.6
|
330.0 mL
Standard Deviation 432.5
|
357.2 mL
Standard Deviation 320
|
SECONDARY outcome
Timeframe: Up to 90 daysPersonal flavor questionnaire to determine flavor preference when using ENDS. Absolute favorite flavor of all most commonly used flavors (i.e. Alcohol， Candy， Chocolate， Clove or Spice， Fruit， Menthol or Mint， Other， Tobacco， Unflavored) are reported.
Outcome measures
| Measure |
Use Own Brand of Flavored Product
n=47 Participants
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
n=41 Participants
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
n=43 Participants
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
|---|---|---|---|
|
Flavor Preference Questionnaire
Don't know
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Flavor Preference Questionnaire
Candy or other sweets
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Flavor Preference Questionnaire
Fruit
|
39 Participants
|
35 Participants
|
33 Participants
|
|
Flavor Preference Questionnaire
Menthol or Mint
|
4 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 daysPopulation: Four visits' data are analyzed. Measurements are taken on Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days
Questions from Wave 1 Adult PATH Survey to measure use and regularity of use flavored products, with the scores ranging of 0 and 100. Data is presented on the percentage of days between sessions participants reported use of product as median and inter-quartile range (IQR). A non-parametric Kruskal-Wallis test followed by Dunn's Multiple Comparisons with Benjamnini-Hochberg adjustment was also performed for each product to assess differences between study groups within a visit, and between visits within a study group.
Outcome measures
| Measure |
Use Own Brand of Flavored Product
n=47 Participants
Participants will use their current flavor of e cigarettes for 90 days
|
Use Provided Tobacco Flavor
n=41 Participants
Participants will use a new assigned flavor for 90 days
|
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
n=43 Participants
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
|
|---|---|---|---|
|
Frequency of Flavored Product Use
Visit 1
|
100 percentage of days
Interval 100.0 to 100.0
|
100 percentage of days
Interval 100.0 to 100.0
|
100 percentage of days
Interval 100.0 to 100.0
|
|
Frequency of Flavored Product Use
Visit 2
|
100 percentage of days
Interval 100.0 to 100.0
|
57.1 percentage of days
Interval 0.0 to 100.0
|
100 percentage of days
Interval 87.9 to 100.0
|
|
Frequency of Flavored Product Use
Visit 3
|
100 percentage of days
Interval 100.0 to 100.0
|
0 percentage of days
Interval 0.0 to 47.6
|
100 percentage of days
Interval 50.0 to 100.0
|
|
Frequency of Flavored Product Use
Visit 4
|
100 percentage of days
Interval 100.0 to 100.0
|
1.6 percentage of days
Interval 0.0 to 100.0
|
100 percentage of days
Interval 48.6 to 100.0
|
Adverse Events
Use Own Brand of Flavored Product
Use Provided Tobacco Flavor
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place