E-cigaretteNCT03742700
Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System
A study testing Cigarette smoking, E-cigarette use and Simulation of the use of e-cigarette in people with E-cigarette, run by Medical University of Silesia.
Trial summary
The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarette
- What is being tested?
- Cigarette smoking, E-cigarette use and Simulation of the use of e-cigarette
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- smoking status (cigarette or e-cigarette smoking)
Who cannot join
- occurrence of any chronic diseases,
- history of lung conditions (eg.: asthma or bronchial hyperactivity in childhood),
- presence of any allergic diseases,
- medication intake within the last 2 weeks,
- acute illnesses or infections in the last 2 weeks,
- influenza vaccination in the last 2 weeks,
- or current pregnancy or lactation.
About this study
The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.
- Conditions
- E-cigarette
- Being tested
- Cigarette smoking, E-cigarette use, Simulation of the use of e-cigarette
- Keywords
- e-cigarette, health effects, cigarette smoking, exhaled nitric oxide, pulmonary function tests
- Medical subject headings
- Vaping, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette smokingBehavioural
T-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits.
E-cigarette useBehavioural
E-smokers and dual users were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
Simulation of the use of e-cigaretteBehavioural
The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).
| Study group | Role | What they receive |
|---|---|---|
| T-smokers | Experimental | T-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits. Receives: Behavioral: Cigarette smoking |
| E-smokers | Experimental | E-smokers were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes. Receives: Behavioral: E-cigarette use |
| T/E-smokers | Experimental | T/E-smokers (dual users) were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes. Receives: Behavioral: E-cigarette use |
| Control subjects | Placebo comparator | The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled). Receives: Behavioral: Simulation of the use of e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
O2 saturation
The O2 measurement was made in the sitting position using the PULSOX 2 electronic pulse meter. The result was recorded 15 seconds after the start of the measurement.
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
Concentration of nitric oxide (FeNO)
FeNO measurements were made using the standard procedure in the sitting position with a clip attached to the nose using a NIOX MINO device for measuring fractional exhaled nitric oxide (FeNO). Subjects were instructed to breathe as deeply as possible through the mouthpiece to achieve maximum lung filling and then to exhale 50ml/sec for 10s. The measured FeNO values were expressed in ppb (parts per billion).
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
exhaled carbon monoxide (CO)
During the measurement, requirements regarding the length and intensity of the exhalation were taken into account. The measurements were made using the PiCo Smokylyzer device. The measured CO levels were expressed in ppm (parts per million).
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
temperature of exhaled air
The measurement was made using the standard procedure in the sitting position using an X-Halo Breath Thermometer [20]. Respondents were instructed to breathe according to the procedure recommended by the device manufacturer. The temperature of exhaled air was expressed in Celsius degrees (°C).
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
spirometric testing
Airflow and lung volume were measured in the sitting position with a noseclip according to the ATS/ERS guidelines. The measurements were made using the EasyOne 2001 spirometer and included FEV1, FVC, FEV1% FVC, PEF and MEF75,50,25. Expiratory maneuvers were repeated until a minimum of three technically correct, repeatable measurements were obtained.
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
heart rate
Heart rate was measured in the sitting position, the result of measurement was expressed in beats per minute.
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
blood pressure
Blood pressure was measured in the sitting position, the result of measurement was expressed in mmHg.
Measured: pre - post (1 minute after exposure) - post (30 minute after exposure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study startJan 2017
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This was a laboratory-based intervention study: pre-post-post
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Jankowski, Medical University of Silesia
- Investigators
- Grzegorz Brożek, MD, PhD, Study director, Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia in Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742700
- Sponsor's protocol ID
- KNW/0022/KB1/37/I/17
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System
- ClinicalTrials.gov ID
- NCT03742700
- Acronym / sponsor ID
- KNW/0022/KB1/37/I/17
- Conditions
- E-cigarette
- Keywords
- e-cigarette, health effects, cigarette smoking, exhaled nitric oxide, pulmonary function tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This was a laboratory-based intervention study: pre-post-post
| Arm | Type | Receives |
|---|---|---|
| T-smokers | Experimental | Behavioral: Cigarette smokingT-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits. |
| E-smokers | Experimental | Behavioral: E-cigarette useE-smokers were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes. |
| T/E-smokers | Experimental | Behavioral: E-cigarette useT/E-smokers (dual users) were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes. |
| Control subjects | Placebo comparator | Behavioral: Simulation of the use of e-cigaretteThe control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- smoking status (cigarette or e-cigarette smoking)
Key exclusion criteria (7 listed)
- occurrence of any chronic diseases,
- history of lung conditions (eg.: asthma or bronchial hyperactivity in childhood),
- presence of any allergic diseases,
- medication intake within the last 2 weeks,
- acute illnesses or infections in the last 2 weeks,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarette smokingT-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits. | Behavioural | T-smokers |
| E-cigarette useE-smokers and dual users were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes. | Behavioural | E-smokers, T/E-smokers |
| Simulation of the use of e-cigaretteThe control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled). | Behavioural | Control subjects |
Primary outcome
O2 saturation
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
The O2 measurement was made in the sitting position using the PULSOX 2 electronic pulse meter. The result was recorded 15 seconds after the start of the measurement.
Concentration of nitric oxide (FeNO)
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
FeNO measurements were made using the standard procedure in the sitting position with a clip attached to the nose using a NIOX MINO device for measuring fractional exhaled nitric oxide (FeNO). Subjects were instructed to breathe as deeply as possible through the mouthpiece to achieve maximum lung filling and then to exhale 50ml/sec for 10s. The measured FeNO values were expressed in ppb (parts per billion).
exhaled carbon monoxide (CO)
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
During the measurement, requirements regarding the length and intensity of the exhalation were taken into account. The measurements were made using the PiCo Smokylyzer device. The measured CO levels were expressed in ppm (parts per million).
temperature of exhaled air
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
The measurement was made using the standard procedure in the sitting position using an X-Halo Breath Thermometer [20]. Respondents were instructed to breathe according to the procedure recommended by the device manufacturer. The temperature of exhaled air was expressed in Celsius degrees (°C).
spirometric testing
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
Airflow and lung volume were measured in the sitting position with a noseclip according to the ATS/ERS guidelines. The measurements were made using the EasyOne 2001 spirometer and included FEV1, FVC, FEV1% FVC, PEF and MEF75,50,25. Expiratory maneuvers were repeated until a minimum of three technically correct, repeatable measurements were obtained.
heart rate
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
Heart rate was measured in the sitting position, the result of measurement was expressed in beats per minute.
blood pressure
Time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)
Blood pressure was measured in the sitting position, the result of measurement was expressed in mmHg.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- E-smoking: Emerging public health problem?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grzegorz Brożek, MD, PhD study director
Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia in Katowice, Poland
Questions about this trial
What is this clinical trial studying?
A study testing Cigarette smoking, E-cigarette use and Simulation of the use of e-cigarette in people with E-cigarette, run by Medical University of Silesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O2 saturation (time frame: pre - post (1 minute after exposure) - post (30 minute after exposure)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.