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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02635620
Acronym
EQualLife
Enrollment
80
Registered
2015-12-21
Start date
2015-10-31
Completion date
2018-05-31
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure to Electronic Cigarettes

Keywords

e-cigarette, electronic cigarette, lung function

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.

Interventions

None listed

Sponsors

Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
lung function3 monthsTiffeneau-Index
quality of life3 monthsWHO quality of life - questionary
respiratory tract inflammation activity3 monthsFeNO (exhaled nitric oxide)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026