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Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD

4. februar 2020 opdateret af: Jacobo Sellarés Torres, Fundacio Catalana de Pneumologia
This study evaluates the local and systemic inflammatory response in the airway in COPD patients who consume electronic cigarettes compared with conventional cigarette smokers.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Chronic obstructive pulmonary disease (COPD) is an illness with high morbidity and mortality in our society with a prevalence of about 10% of the population. Smoking represents the main risk factor for development of COPD having been associated with a greater decrease in lung capacity and increased mortality. Therefore, early treatment of smoking habit is an essential therapeutic approach.

The first line drug treatments have proven effective for smoking cessation, on the other hand the introduction of electronic cigarettes has brought a wide impact on our society,being considered as possible replacements in patients with difficulties in quitting the habit; however there is still limited information on its use in addition to some undesirable effects that have been described such as the lipoid pneumonia.

Recent clinical trials have shown that the use of electronic cigarettes may be associated with symptoms like dry cough, mouth irritation, dyspnea, and headache. On the other hand it has also been associated with increased airway resistance, an immediate decrease of exhaled nitric oxide (FeNO) and FEV1.

Our study aim to assess the inflammatory response in COPD patients who are regular consumers of electronic cigarettes compared with conventional cigarette smokers. The inclusion criteria in the study are: male patients diagnosed with COPD Gold B and C according to international guidelines that are regular smokers with no desire to quit their smoking habit. Exclusion criteria includes those with serious cardiovascular disease, chronic inflammatory disease, active oncologic disease of any origin, use of corticosteroids or other drugs with anti-inflammatory effect and finally COPD patients with acute exacerbation in the last twelve weeks.

Patients will be randomized into two groups: users of conventional and electronic cigarette. All patients in the second group will be provided with the same type of electronic cigarette and doses of inhaled nicotine.

We will perform a complete clinical characterization of the patients collecting data related with their smoking habit, daily consumption, tests to assess the degree of dependence and withdrawal symptoms, level of dyspnea and symptoms associated with tobacco consumption.

We will perform a complete respiratory functional test including spirometry, diffusion capacity and measurement of exhaled carbon monoxide levels. Inflammatory involvement of the airway will be examined by assessing the concentration of exhaled nitric oxide, studying the percentage of neutrophils and eosinophils in induced sputum and a general analysis for determination of inflammatory mediators: IL1B, IL6, IL8, factor alpha and C-reactive protein tumor necrosis.

The results will be evaluated by statistical tests. The results obtained will provide us with information about the effect of the electronic cigarette in COPD and its effectiveness in smoking cessation.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

10

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Barcelona, Spanien, 08036
        • Hospital Clínic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Male patients diagnosed with COPD Gold B or C according to international guidelines who have not had and acute exacerbation in the last 12 weeks prior to their inclusion in the study.

Beskrivelse

Inclusion Criteria:

  • COPD patients Gold B or C
  • Regular smokers with no desire to quit their habit.

Exclusion Criteria:

  • Severe cardiovascular diseases.
  • Chronic inflammatory diseases.
  • Active oncologic diseases.
  • Treatment with corticosteroids or other antiinflammatory drugs.
  • Acute exacerbation of COPD in the last 12 weeks previous to their inclusion in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
COPD patients & conventional cigarettes
COPD patients regular smokers of conventional cigarettes with no desire to quit smoking habit.
COPD patients & electronic cigarettes
COPD patients who had been users of electronic cigarettes for at least 8 weeks. They will be provided with an specific type of electronic cigarette and the same dosage of inhaled nicotine.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of inflammatory response
Tidsramme: 8 weeks
Assessment of the local inflammatory airway response measured by respiratory functional test and sputum culture, in addition to the evaluation of the systemic inflammatory response provided by determination of acute reactants in blood tests (determination of C-reactive protein and cytokines in blood sample) in COPD patients.
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical symptoms associated with COPD
Tidsramme: 8 weeks
Complete characterization of patients: tobacco consumption related symptoms: cough, oral irritation, dyspnoea. Control of the symptoms of nicotine withdrawal and evaluation test.
8 weeks
Tobacco withdrawal
Tidsramme: 8 weeks
Maintained smoking abstinence rate at 8 weeks in the electronic cigarette group.
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2016

Primær færdiggørelse (Faktiske)

1. august 2018

Studieafslutning (Faktiske)

1. marts 2019

Datoer for studieregistrering

Først indsendt

24. august 2016

Først indsendt, der opfyldte QC-kriterier

1. september 2016

Først opslået (Skøn)

8. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STUDY ECIGPOC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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