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OpenTrials
Completed

NCT Number: NCT02102191

Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

Because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known toxins found in conventional cigarette smoke.However e-Cigarettes with low dose of tobacco were found to have immediate adverse physiologic effects after short-term use that are similar to some of the effects seen with tobacco smoking.

In this study we wanted to assess the short-time effect of one e-cigarette with no tobacco vs a "traditional" cigarette.

10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.

Completed

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Key information

Conditions

Individuality

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Salvatore Maugeri

Pavia, Province, 27100, Italy

About this study

On day 1 the subjects will be asked to smoke either the e-cigarette or a "traditional" one for 5 minutes. On day 2 the subject will be ask to smoke for 5 minutes the other kind of cigarette.

Exhaled Nitric Oxide will be measured in a sitting position with a nose clip using an analyzer equipped with a software program. The patient will be instructed to inhale as deeply as possible to total lung capacity through a filter mouthpiece and consecutively exhale at a mouth fl ow rate of 50 mL/s for 10 s. Three consecutive trials will be performed with a 30-s interval.

Dynamic Lung Volumes: Flows and lung volumes will be measured in the sitting position, a spirometry system (heated pneumotach, with the highest FEV 1 recorded in line with pulmonary guidelines. Spirometry will be measured according to the recommendations of the American Thoracic Society/European Respiratory Society task force guidelines. FEV 1, FVC, FEV 1 %, peak expiratory fl ow (PEF), and maximal expiratory fl ow (MEF) at 25%, 50%, and 75% of vital capacity will be measured. Each maneuver will be repeated for at least three technically acceptable forced expiratory fl ow curves.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 10 no smoking healthy individuals
  • 10 smoking (>20 pack/yr) healthy individuals

Exclusion criteria

  • pre-existing diseases
  • FEV1/FVC ratio<70%

Treatment and study plan

E-cigarette

Device

smoking cigarette without tobacco

cigarette

Device

smoking cigarette with tobacco

Primary outcomes

  1. spirometric data

    Time frame: five minutes

Secondary outcomes

  1. nitric oxyde level

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • Fondazione Salvatore Maugeri

Registry information

Official study title

Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking: a RCT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2014
Registry last updated
Oct 7, 2014

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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