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

Completed

• Conditions: Exposure to Electronic Cigarettes

• Registration Number: NCT02635620
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of life	3 months	WHO quality of life - questionary
lung function	3 months	Tiffeneau-Index
respiratory tract inflammation activity	3 months	FeNO (exhaled nitric oxide)

Trial Locations

Locations (1)

Klinik für Psychiatrie und Psychotherapie - LMU Munich; 🇩🇪 Munich, Bavaria, Germany