- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03153228
Acute Response to Cigarette and E-cigarette Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and E-cigarettes
The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.
Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system.
The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The aim of the study is:
- to evaluate the acute response to traditional cigarettes on the respiratory system
- to evaluate the acute response to electronic cigarettes on the respiratory system
- to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers
Material and methods:
- 29 healthy smokers of traditional cigarettes
- 29 healthy smokers of electronic cigarettes
- 29 healthy, nonsmoking volunteers
After 8 hours of smoking abstinence:
- the spirometry test
- the first collection of the exhaled breath condensate (EBC I)
- smoking a traditional / electronic cigarette
- the second collection of the exhaled breath condensate (EBC II) - one hour after smoking
- the third collection of the exhaled breath condensate (EBC III) - six hours after smoking
- the measurement of biomarkers of oxidative stress in the EBC (isoprostane-8, malondialdehyde MDA, IL-8) and pH of the EBC
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Warsaw, Polen, 02-097
- Medical University of Warsaw, Banacha Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- healthy smokers of traditional cigarettes - min. 1 packyear
- healthy smokers of e-cigarettes - min. 1 year of smoking history
- control group - healthy nonsmoking volunteers without any history of lung disease
Exclusion Criteria:
- age below 18 years
- inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
- any co-morbidities
- respiratory infections at least 6 weeks prior to study enrollment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Smokers of traditional cigarettes
29 healthy smokers of traditional cigarettes (min. 1 packyear)
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Smokers of e-cigarettes
29 healthy smokers of e-cigarettes (min. 1 packyear)
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Control
29 healthy volunteers.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Inflammatory markers in exhaled breath condensate
Tidsramme: Approximately 1-2 months after completion of study procedures in all patients
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Inflammatory markers in exhaled breath condensate in healthy subjects, smokers of traditional cigarettes and e-cigarette smokers
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Approximately 1-2 months after completion of study procedures in all patients
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IPU-DIMPA-WUM13(2)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med E-cigaretter
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Seok Hyun GwonRekruttering
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The University of Texas Health Science Center,...National Cancer Institute (NCI)Aktiv, ikke rekrutterendeBrug af e-cigaretForenede Stater
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University of VermontNational Institute on Drug Abuse (NIDA)AfsluttetBrug af elektronisk cigaret | Vaping | Brug af e-cigaretForenede Stater
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University of California, San DiegoIkke rekrutterer endnuBrug af E-cigaret
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Western University, CanadaLondon Health Sciences CentreRekrutteringBrug af E-cigaretCanada
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Ohio State University Comprehensive Cancer CenterRekrutteringBrug af e-cigaretForenede Stater
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University of CincinnatiAktiv, ikke rekrutterendeBrug af e-cigaretForenede Stater
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Stanford UniversityNational Cancer Institute (NCI)Tilmelding efter invitationBrug af e-cigaretForenede Stater