Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

Individuality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102191
• Other study ID #: 972CE
• Secondary ID: 23
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: October 5, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Individuality

Intervention

Device:
• e-cigarette
smoking cigarette without tobacco
• cigarette
smoking cigarette with tobacco

Locations

Country	Name	City	State
Italy	Fondazione Salvatore Maugeri	Pavia	Province

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spirometric data		five minutes	No
Secondary	nitric oxyde level		5 minutes	No