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Completed

NCT Number: NCT02635620

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Psychiatrie und Psychotherapie - LMU Munich

Munich, Bavaria, 80336, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. lung function

    Time frame: 3 months

    Tiffeneau-Index

  2. quality of life

    Time frame: 3 months

    WHO quality of life - questionary

  3. respiratory tract inflammation activity

    Time frame: 3 months

    FeNO (exhaled nitric oxide)

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Acronym: EQualLife

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2015
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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