Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

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

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.

Study Overview

• Status: Completed
• Conditions: Individuality
• Intervention / Treatment: Device: e-cigarette; Device: cigarette

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Province
    • Pavia, Province, Italy, 27100
      • Fondazione Salvatore Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cigarette; common cigarette sold in the stores	Device: e-cigarette; smoking cigarette without tobacco; Device: cigarette; smoking cigarette with tobacco
Active Comparator: e-cigarette; e-cigarette (Ovale Elips)	Device: e-cigarette; smoking cigarette without tobacco; Device: cigarette; smoking cigarette with tobacco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
spirometric data	five minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
nitric oxyde level	5 minutes

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: Fondazione Salvatore Maugeri
• Investigators: Study Chair: stefano nava, md, AO Sant'Orsola

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Estimate): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 5, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 972CE; 23 (SIME)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No