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Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02102191
Enrollment
20
Registered
2014-04-02
Start date
2014-03-31
Completion date
2014-10-31
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuality

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.

Interventions

DEVICEe-cigarette

smoking cigarette without tobacco

DEVICEcigarette

smoking cigarette with tobacco

Sponsors

Fondazione Salvatore Maugeri
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* pre-existing diseases * FEV1/FVC ratio\<70%

Design outcomes

Primary

MeasureTime frame
spirometric datafive minutes

Secondary

MeasureTime frame
nitric oxyde level5 minutes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026