NCT02102191

Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Individuality

Interventions

Type	Name	Description
DEVICE	e-cigarette	smoking cigarette without tobacco
DEVICE	cigarette	smoking cigarette with tobacco

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-04-02
• Last updated: 2014-10-07

Locations

1 site across 1 country: Italy