Changes in Psychological and Somatic Parameters Associated With Changing From Smoking to E-cigarettes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changes in Lung Function Parameters, Bronchial Reactivity, State of Health and Smoking Behaviour Associated With Changing From Conventional Smoking to Electronic Cigarettes

Conditions
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Exposure to Electronic Cigarettes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| e-cigarette group<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function | Tiffeneau-Index | 3 months | 
| quality of life | WHO quality of life - questionary | 3 months | 
| respiratory tract inflammation activity | FeNO (exhaled nitric oxide) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarette, electronic cigarette, lung function