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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

NCT number NCT02892396
Study type Observational
Source Fundacio Catalana de Pneumologia
Contact Jacobo Sellares, Doctor
Phone +1 (412)320-1095
Status Not yet recruiting
Phase N/A
Start date September 2016
Completion date March 2019

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