Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of inflammatory response
研究概览
简要总结
This study evaluates the local and systemic inflammatory response in the airway in COPD patients who consume electronic cigarettes compared with conventional cigarette smokers.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •COPD patients Gold B or C
- •Regular smokers with no desire to quit their habit.
排除标准
- •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
结局指标
主要结局
Evaluation of inflammatory response
时间窗: 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.
次要结局
- Clinical symptoms associated with COPD(8 weeks)
- Tobacco withdrawal(8 weeks)
研究者
Jacobo Sellarés Torres
Doctor in Medicine
Fundacio Catalana de Pneumologia