Clinical trial NCT02635620: Changes in Psychological and Somatic Parameters Associated With Changing From Smoking to E-cigarettes
Official title: Changes in Lung Function Parameters, Bronchial Reactivity, State of Health and Smoking Behaviour Associated With Changing From Conventional Smoking to Electronic Cigarettes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Electronic Cigarettes
Keywords: e-cigarette, electronic cigarette, lung function
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* pregnancy or breastfeeding
* not speaking German
* known allergy
* acute psychiatric diseases, suicidal tendency
* drug/substance/alcohol abuse
* severe internal diseases

Primary outcomes:
measure: lung function
timeFrame: 3 months
measure: quality of life
timeFrame: 3 months
measure: respiratory tract inflammation activity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie - LMU Munich
state: Bavaria
Study officials:
affiliation: LMU - Munich
name: Tobias Rüther, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schober 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.
citation: Lerner 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.
citation: Lim 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.
citation: Wu 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.
citation: Vardavas 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.