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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients & conventional cigarettes<br>COPD patients regular smokers of conventional cigarettes with no desire to quit smoking habit. | |
| COPD patients & electronic cigarettes<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of inflammatory response | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms associated with COPD | 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 | Maintained smoking abstinence rate at 8 weeks in the electronic cigarette group. | 8 weeks |