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Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.

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ClinicalTrials.gov Identifier: NCT03301129
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Coluzzi Flaminia
Peruzzi Mariangela
Nocella Cristina
Loffredo Lorenzo
Marullo Antonino G.M.
Valenti Valentina
Chimenti Isotta
De Falco Elena
Sciarretta Sebastiano
Information provided by (Responsible Party):
Roberto Carnevale, University of Roma La Sapienza

Brief Summary:
Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.

Condition or disease Intervention/treatment Phase
Oxidative Stress Induction Endothelial Dysfunction Platelet Activation Behavioral: Smoke Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
Actual Study Start Date : October 15, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : February 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Traditional cigarette
smoke one Traditional cigarette (with a mean nicotine content of 0.6 mg according to package label) and in a sub-group smoke a sham cigarette (an traditional cigarette without combustion).
Behavioral: Smoke
See arm/group descriptions.

Experimental: Electronic cigarette
smoke a tobacco-flavored Electronic cigarette (9 puffs approximately equivalent to 0.6 mg of nicotine content) and in a sub-group smoke a sham cigarette (an electronic cigarette without nicotine).
Behavioral: Smoke
See arm/group descriptions.

Experimental: Heat-not-burn tobacco products (IQOS)
smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label).
Behavioral: Smoke
See arm/group descriptions.




Primary Outcome Measures :
  1. Endothelial dysfunction [ Time Frame: up to 24 weeks ]
    flow-mediated dilatation (FMD) assessed by vascular ultrasound

  2. Oxidative stress [ Time Frame: up to 24 weeks ]
    Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation


Secondary Outcome Measures :
  1. Platelet activation [ Time Frame: up to 24 weeks ]
    evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smokers volunteers, minimum age 18 years

Exclusion Criteria:

  • no history of acute or chronic organic, metabolic and inflammatory diseases;
  • no fever and infections in the last 3 months;
  • no history of cardiovascular pathological symptoms;
  • no allergies;
  • none of the participants took vitamin E, other antioxidant supplements or other drugs potentially affecting oxidative stress or FMD
  • women were not menstruating when the experiment was performed.

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): NCT03301129


Locations
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Italy
Sapienza University
Roma, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Coluzzi Flaminia
Peruzzi Mariangela
Nocella Cristina
Loffredo Lorenzo
Marullo Antonino G.M.
Valenti Valentina
Chimenti Isotta
De Falco Elena
Sciarretta Sebastiano
Investigators
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Study Director: Giacomo Frati, MD Sapienza University of Rome, Policlinico Umberto I

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Responsible Party: Roberto Carnevale, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03301129     History of Changes
Other Study ID Numbers: 3241
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: identified individual participant data for all outcomes measures will be made available to other reserachers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No