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Clinical Trials/NCT02635620
NCT02635620CompletedNot Applicable

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

Ludwig-Maximilians - University of Munich1 site in 1 country80 target enrollmentStarted: October 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
lung function

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

lung function

Time Frame: 3 months

Tiffeneau-Index

respiratory tract inflammation activity

Time Frame: 3 months

FeNO (exhaled nitric oxide)

quality of life

Time Frame: 3 months

WHO quality of life - questionary

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oliver Pogarell

Prof. Dr.

Ludwig-Maximilians - University of Munich

Study Sites (1)

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