Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD
Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD
This study evaluates the local and systemic inflammatory response in the airway in COPD
 patients who consume electronic cigarettes compared with conventional cigarette smokers.
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.
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