Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Individuality

Intervention / Treatment
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* Device: e-cigarette
* Device: cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 no smoking healthy individuals 10 smoking (>20 pack/yr) healthy individuals Exclusion Criteria: pre-existing diseases FEV1/FVC ratio<70%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cigarette<br>common cigarette sold in the stores | Device: e-cigarette<br>* smoking cigarette without tobacco<br>Device: cigarette<br>* smoking cigarette with tobacco<br>|
| Active Comparator: e-cigarette<br>e-cigarette (Ovale Elips) | Device: e-cigarette<br>* smoking cigarette without tobacco<br>Device: cigarette<br>* smoking cigarette with tobacco<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spirometric data |  | five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nitric oxyde level |  | 5 minutes |