Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

Not Applicable

Completed

• Conditions: Individuality
• Interventions: Device: e-cigarette; Device: cigarette

• Registration Number: NCT02102191
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-02
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-05
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
e-cigarette	e-cigarette	e-cigarette (Ovale Elips)
cigarette	e-cigarette	common cigarette sold in the stores
cigarette	cigarette	common cigarette sold in the stores
e-cigarette	cigarette	e-cigarette (Ovale Elips)

Primary Outcome Measures

Name	Time	Method
spirometric data	five minutes

Secondary Outcome Measures

Name	Time	Method
nitric oxyde level	5 minutes

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri; 🇮🇹 Pavia, Province, Italy