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Trial record 1 of 1 for:    NCT02102191
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Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102191
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : October 7, 2014
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Description
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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.


Condition or disease Intervention/treatment Phase
Individuality Device: e-cigarette Device: cigarette Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking: a RCT
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. spirometric data [ Time Frame: five minutes ]

Secondary Outcome Measures :
  1. nitric oxyde level [ Time Frame: 5 minutes ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pre-existing diseases
  • FEV1/FVC ratio<70%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102191


Locations
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Italy
Fondazione Salvatore Maugeri
Pavia, Province, Italy, 27100
Sponsors and Collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Fondazione Salvatore Maugeri
Investigators
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Study Chair: stefano nava, md AO Sant'Orsola
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: dr. Stefano Nava, professor of respiratory disease, IRCCS Azienda Ospedaliero-Universitaria di Bologna
ClinicalTrials.gov Identifier: NCT02102191    
Other Study ID Numbers: 972CE
23 ( Other Identifier: SIME )
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014