NCT02102191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

March 27, 2014

Last Update Submit

October 5, 2014

Conditions

Individuality

Outcome Measures

Primary Outcomes (1)

  • spirometric data

    five minutes

Secondary Outcomes (1)

  • nitric oxyde level

    5 minutes

Study Arms (2)

cigarette

ACTIVE COMPARATOR

common cigarette sold in the stores

Device: e-cigaretteDevice: cigarette

e-cigarette

ACTIVE COMPARATOR

e-cigarette (Ovale Elips)

Device: e-cigaretteDevice: cigarette

Interventions

e-cigaretteDEVICE

smoking cigarette without tobacco

cigarettee-cigarette
cigaretteDEVICE

smoking cigarette with tobacco

cigarettee-cigarette

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Salvatore Maugeri

Pavia, Province, 27100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26459355DERIVED

Study Officials

  • stefano nava, md

    AO Sant'Orsola

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of respiratory disease

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 2, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

IT(1)