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| ID | Type | Description | Link |
|---|---|---|---|
| 23 | Other Identifier | SIME |
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| Name | Class |
|---|---|
| Fondazione Salvatore Maugeri | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cigarette | Active Comparator | common cigarette sold in the stores |
|
| e-cigarette | Active Comparator | e-cigarette (Ovale Elips) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-cigarette | Device | smoking cigarette without tobacco |
| |
| Measure | Description | Time Frame |
|---|---|---|
| spirometric data | five minutes |
| Measure | Description | Time Frame |
|---|---|---|
| nitric oxyde level | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| stefano nava, md | AO Sant'Orsola | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Salvatore Maugeri | Pavia | Province | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26459355 | Derived | 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. |
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| cigarette |
| Device |
smoking cigarette with tobacco |
|