Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study evaluates the local and systemic inflammatory response in the airway in COPD
      patients who consume electronic cigarettes compared with conventional cigarette smokers.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      -  Blood sample for study of inflammatory mediators.

        -  Induced sputum culture