Exposure to Electronic CigarettesEQualLifeNCT02635620
Changes in Psychological and Somatic Parameters Associated With Changing From Smoking to E-cigarettes
An observational study of Exposure to Electronic Cigarettes, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to investigate whether changing from conventional smoking to electronic cigarettes causes changes in conventional lung function parameters, bronchial reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and smoking behaviour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exposure to Electronic Cigarettes
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to May 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of smokers who want to start using electronic cigarettes. Control group contains smokers who stop smoking in the framework of a clinical conducted program.
Who may be able to join
- smoking ≥ 5 years
- smoking ≥ 10 cigarettes per day
- no intention to stop smoking within the last 3 months
- using e-cigarettes with nicotine
- no infection of airways at the time of measurements
- e-cigarette group: intending to use e-cigarettes
- control group: smoking cessation in the framework of a clinical conducted program
Who cannot join
- pregnancy or breastfeeding
- not speaking German
- known allergy
- acute psychiatric diseases, suicidal tendency
- drug/substance/alcohol abuse
- severe internal diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Psychiatrie und Psychotherapie - LMU Munich
Munich, Bavaria, 80336
About this study
Official title: Changes in Lung Function Parameters, Bronchial Reactivity, State of Health and Smoking Behaviour Associated With Changing From Conventional Smoking to Electronic Cigarettes
The purpose of this study is to investigate whether changing from conventional smoking to electronic cigarettes causes changes in conventional lung function parameters, bronchial reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and smoking behaviour.
Read the detailed description
STUDY BACKGROUND / RATIONALE / PURPOSE:
There is still little known about the health effects by vaping electronic cigarettes. Some former studies investigated the short term effects of vaping regarding lung function, respiratory resistance and FeNO (fractional exhaled nitric oxide). Flouris et al., 2013 did not found significant short term effects on conventional lung function parameters. Vardavas et al., 2012 also found no short term effects on conventional lung function parameters, but an increase of respiratory resistance and a decrease of FeNO. In contrast, Schober et al., 2014 observed an increase of FeNO after vaping electronic cigarettes.
Experimental studies have shown, that electronic cigarettes induce an inflammatory process in epithelial cells (Lerner et al., 2015; Wu, Jiang, Minor, and Chu, 2014). Lim and Kim, 2014 investigated the effects of e-liquids on the airway reactivity and inflammation on allergic sensitized mice. Reactivity and inflammation got worse.
Long term data is still missing. For this purpose we want to investigate lung function, airway reactivity, health status and smoking/vaping behaviour in smokers at the time they intend to start vaping and after 3 months.
- Conditions
- Exposure to Electronic Cigarettes
- Keywords
- e-cigarette, electronic cigarette, lung function
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| e-cigarette group | Probands are smokers who intend to start vaping for the first time. The probands are recruited in e-cigarette shops. It is aimed to include 60 persons who start vaping. A baseline visit at the beginning will measure conventional lung function parameters, mannitol provocation, FeNO and exhaled CO. The measurement will be repeated after 3 months to evaluate changes in these parameters. In addition there will be questionnaires concerning smoking/vaping behaviour and health status at the beginning and after 1, 2 and 3 months. | |
| smoking cessation group | Probands are smokers who intend to quit smoking within a clinical conducted smoking cessation program. It is aimed to include 20 persons who stop smoking. Like in the e-cigarette group, a baseline visit at the beginning will measure conventional lung function parameters, mannitol provocation, FeNO and exhaled CO. The measurement will be repeated after 3 months to evaluate changes in these parameters. In addition there will be questionnaires concerning smoking behaviour and health status at the beginning and after 1, 2 and 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung function
Tiffeneau-Index
Measured: 3 months
quality of life
WHO quality of life - questionary
Measured: 3 months
respiratory tract inflammation activity
FeNO (exhaled nitric oxide)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Exposure to Electronic CigarettesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Pogarell, Ludwig-Maximilians - University of Munich
- Investigators
- Tobias Rüther, Dr., Principal investigator, LMU - Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635620
- Sponsor's protocol ID
- EQualLife
- Acronym
- EQualLife
- Status last verified
- Jan 2019
- First submitted
- 11 Dec 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Flouris AD, Chorti MS, Poulianiti KP, Jamurtas AZ, Kostikas K, Tzatzarakis MN, Wallace Hayes A, Tsatsakis AM, Koutedakis Y. Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function. Inhal Toxicol. 2013 Feb;25(2):91-101. doi: 10.3109/08958378.2012.758197.
PubMed 23363041Schober W, Szendrei K, Matzen W, Osiander-Fuchs H, Heitmann D, Schettgen T, Jorres RA, Fromme H. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health. 2014 Jul;217(6):628-37. doi: 10.1016/j.ijheh.2013.11.003. Epub 2013 Dec 6.
PubMed 24373737Lerner CA, Sundar IK, Yao H, Gerloff J, Ossip DJ, McIntosh S, Robinson R, Rahman I. Vapors produced by electronic cigarettes and e-juices with flavorings induce toxicity, oxidative stress, and inflammatory response in lung epithelial cells and in mouse lung. PLoS One. 2015 Feb 6;10(2):e0116732. doi: 10.1371/journal.pone.0116732. eCollection 2015.
PubMed 25658421Lim HB, Kim SH. Inhallation of e-Cigarette Cartridge Solution Aggravates Allergen-induced Airway Inflammation and Hyper-responsiveness in Mice. Toxicol Res. 2014 Mar;30(1):13-8. doi: 10.5487/TR.2014.30.1.013.
PubMed 24795794Wu Q, Jiang D, Minor M, Chu HW. Electronic cigarette liquid increases inflammation and virus infection in primary human airway epithelial cells. PLoS One. 2014 Sep 22;9(9):e108342. doi: 10.1371/journal.pone.0108342. eCollection 2014.
PubMed 25244293Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22.
PubMed 22194587
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Lung Function Parameters, Bronchial Reactivity, State of Health and Smoking Behaviour Associated With Changing From Conventional Smoking to Electronic Cigarettes
- ClinicalTrials.gov ID
- NCT02635620
- Acronym / sponsor ID
- EQualLife / EQualLife
- Conditions
- Exposure to Electronic Cigarettes
- Keywords
- e-cigarette, electronic cigarette, lung function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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 purpose of this study is to investigate whether changing from conventional smoking to electronic cigarettes causes changes in conventional lung function parameters, bronchial reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and smoking behaviour.
Detailed description
STUDY BACKGROUND / RATIONALE / PURPOSE:
There is still little known about the health effects by vaping electronic cigarettes. Some former studies investigated the short term effects of vaping regarding lung function, respiratory resistance and FeNO (fractional exhaled nitric oxide). Flouris et al., 2013 did not found significant short term effects on conventional lung function parameters. Vardavas et al., 2012 also found no short term effects on conventional lung function parameters, but an increase of respiratory resistance and a decrease of FeNO. In contrast, Schober et al., 2014 observed an increase of FeNO after vaping electronic cigarettes.
Experimental studies have shown, that electronic cigarettes induce an inflammatory process in epithelial cells (Lerner et al., 2015; Wu, Jiang, Minor, and Chu, 2014). Lim and Kim, 2014 investigated the effects of e-liquids on the airway reactivity and inflammation on allergic sensitized mice. Reactivity and inflammation got worse.
Long term data is still missing. For this purpose we want to investigate lung function, airway reactivity, health status and smoking/vaping behaviour in smokers at the time they intend to start vaping and after 3 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-cigarette group | – | –Probands are smokers who intend to start vaping for the first time. The probands are recruited in e-cigarette shops. It is aimed to include 60 persons who start vaping. A baseline visit at the beginning will measure conventional lung function parameters, mannitol provocation, FeNO and exhaled CO. The measurement will be repeated after 3 months to evaluate changes in these parameters. In addition there will be questionnaires concerning smoking/vaping behaviour and health status at the beginning and after 1, 2 and 3 months. |
| smoking cessation group | – | –Probands are smokers who intend to quit smoking within a clinical conducted smoking cessation program. It is aimed to include 20 persons who stop smoking. Like in the e-cigarette group, a baseline visit at the beginning will measure conventional lung function parameters, mannitol provocation, FeNO and exhaled CO. The measurement will be repeated after 3 months to evaluate changes in these parameters. In addition there will be questionnaires concerning smoking behaviour and health status at the beginning and after 1, 2 and 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of smokers who want to start using electronic cigarettes. Control group contains smokers who stop smoking in the framework of a clinical conducted program.
Key inclusion criteria (7 listed)
- smoking ≥ 5 years
- smoking ≥ 10 cigarettes per day
- no intention to stop smoking within the last 3 months
- using e-cigarettes with nicotine
- no infection of airways at the time of measurements
Key exclusion criteria (6 listed)
- pregnancy or breastfeeding
- not speaking German
- known allergy
- acute psychiatric diseases, suicidal tendency
- drug/substance/alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lung function
Time frame: 3 months
Tiffeneau-Index
quality of life
Time frame: 3 months
WHO quality of life - questionary
respiratory tract inflammation activity
Time frame: 3 months
FeNO (exhaled nitric oxide)
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 16 Jan 2019.
- Background: PubMed 23363041Flouris AD, Chorti MS, Poulianiti KP, Jamurtas AZ, Kostikas K, Tzatzarakis MN, Wallace Hayes A, Tsatsakis AM, Koutedakis Y. Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function. Inhal Toxicol. 2013 Feb;25(2):91-101. doi: 10.3109/08958378.2012.758197.
- Background: PubMed 24373737Schober W, Szendrei K, Matzen W, Osiander-Fuchs H, Heitmann D, Schettgen T, Jorres RA, Fromme H. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health. 2014 Jul;217(6):628-37. doi: 10.1016/j.ijheh.2013.11.003. Epub 2013 Dec 6.
- Background: PubMed 25658421Lerner CA, Sundar IK, Yao H, Gerloff J, Ossip DJ, McIntosh S, Robinson R, Rahman I. Vapors produced by electronic cigarettes and e-juices with flavorings induce toxicity, oxidative stress, and inflammatory response in lung epithelial cells and in mouse lung. PLoS One. 2015 Feb 6;10(2):e0116732. doi: 10.1371/journal.pone.0116732. eCollection 2015.
- Background: PubMed 24795794Lim HB, Kim SH. Inhallation of e-Cigarette Cartridge Solution Aggravates Allergen-induced Airway Inflammation and Hyper-responsiveness in Mice. Toxicol Res. 2014 Mar;30(1):13-8. doi: 10.5487/TR.2014.30.1.013.
- Background: PubMed 25244293Wu Q, Jiang D, Minor M, Chu HW. Electronic cigarette liquid increases inflammation and virus infection in primary human airway epithelial cells. PLoS One. 2014 Sep 22;9(9):e108342. doi: 10.1371/journal.pone.0108342. eCollection 2014.
- Background: PubMed 22194587Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22.
- 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.
Tobias Rüther, Dr. principal investigator
LMU - Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Electronic Cigarettes, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 7 inclusion and 6 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
lung function (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635620, which also lists 6 linked publications.
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 16 Jan 2019.