Clinical Trials Directory

Trials / Completed

CompletedNCT02635620

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Ludwig-Maximilians - University of Munich · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2015-10-01
Primary completion
2018-05-01
Completion
2018-05-01
First posted
2015-12-21
Last updated
2019-01-16

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02635620. Inclusion in this directory is not an endorsement.