Clinical trial NCT02102191: Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking
Official title: Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking: a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuality
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Fondazione Salvatore Maugeri
First posted: 2014-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: spirometric data
timeFrame: five minutes
Secondary outcomes:
measure: nitric oxyde level
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
state: Province
Study officials:
affiliation: AO Sant'Orsola
name: stefano nava, md
role: STUDY_CHAIR
References:
citation: Ferrari M, Zanasi A, Nardi E, Morselli Labate AM, Ceriana P, Balestrino A, Pisani L, Corcione N, Nava S. Short-term effects of a nicotine-free e-cigarette compared to a traditional cigarette in smokers and non-smokers. BMC Pulm Med. 2015 Oct 12;15:120. doi: 10.1186/s12890-015-0106-z.