EUCTR2012-003253-28-ES进行中（未招募）不适用
Randomized double-blind placebo-controlled prospective, parallel, multicentre clinical trial of bacterial polivalent vaccine (BACTEK ®)administered by sublingual mucosa in subjects with chronic obstructive pulmonary disease (COPD) for eficacy evaluation, security and immunomodulatory response.
Inmunotek S.L.0 个研究点开始时间: 2012年10月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Written informed consent.
- •?Both gender
- •?Age between 35 and 85.
- •?Must be able to follow the treatment regimen
- •?Diagnosis of moderate COPD according to GOLD criteria:
- •Post-bronchodilator FEV1/FVC <70%,
- •Post-bronchodilator FEV1 <80% predicted, with or without chronic symptoms (eg, cough, sputum production).
- •?Consumption of 10 or more packs of cigarettes / year. The subject may or may not be active smokers.
- •?The subject included in this clinical trial must live in the Community of Madrid from September to May during the clinical trial period
- •?The subject included in the clinical trial must have been vaccinated with pneumococcal polysaccharide vaccine at least 4 weeks before administration of Bactek ®
- •?To increase the population of subjects that are more prone to have acute exacerbations each individual must meet one or more of the following four conditions:
- •- Use or have used supplementary O2 (except O2 home use)
- •- Have received systemic corticosteroids for respiratory problems in the last year
- •- Having gone to the emergency room, at least one exacerbation of COPD in the last year
- •- Have been hospitalized due to exacerbation of COPD in the last year
- •?Fertile women of must use an approved contraceptive method (oral, vaginal, transdermal, etc. IUDs or barrier methods) and get a negative pregnancy test in urine made during the selection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •?Subject outside of age range
- •? Subject unable to offer cooperation and / or have severe psychiatric disorders
- •?Pregnant women, breastfeeding or wishing to become pregnant during the study (including assisted reproductive processes), or to reject the use of contraception during the study (including barrier). Women who become pregnant will have to discontinue their participation in this clinical trial.
- •?Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion
- •? Subject diagnosed with asthma according to American Thoracic Society and European Respiratory Society.guidelines
- •?The presence of another diagnosis other than COPD that makes the subject unstable or has a life expectancy <3 years
- •?Subject who has had an exacerbation 4 weeks before starting the trial.
- •?Subject that have needed inhaled corticosteroids in the last 4 weeks before starting the trial
- •?Subject who has received systemic corticosteroids (vo, im, iv) in the last 4 weeks.
- •?Subject diagnosed with Primary or Secondary Immunodeficiency (ESID criteria) 12 months prior to inclusion in the trial
- •?Subjects with chronic lymphoproliferative disease
- •?Subjects with chronic infectious disease (TB, HCV, HIV, HBV)
- •?Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
- •? Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa
- •?Subject with COPD and bronchiectasis diagnosed by CT image before age 40
- •? Subject with severe COPD
- •?Subject requiring home O2 or Noninvasive Mechanical Ventilation
- •?Subject with a history of hypersensitivity to any component of the vaccine
- •?Subject outside of age range
- •? Subject unable to offer cooperation and / or have severe psychiatric disorders
- •?Pregnant women, breastfeeding or wishing to become pregnant during the study (including assisted reproductive processes), or to reject the use of contraception during the study (including barrier). Women who become pregnant will have to discontinue their participation in this clinical trial.
- •?Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion
- •? Subject diagnosed with asthma according to American Thoracic Society and European Respiratory Society.guidelines
- •?The presence of another diagnosis other than COPD that makes the subject unstable or has a life expectancy <3 years
- •?Subject who has had an exacerbation 4 weeks before starting the trial.
- •?Subject that have needed inhaled corticosteroids in the last 4 weeks before starting the trial
- •?Subject who has received systemic corticosteroids (vo, im, iv) in the last 4 weeks.
- •?Subject diagnosed with Primary or Secondary Immunodeficiency (ESID criteria) 12 months prior to inclusion in the trial
- •?Subjects with chronic lymphoproliferative disease
- •?Subjects with chronic infectious disease (TB, HCV, HIV, HBV)
- •?Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
- •? Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa
- •?Subject with COPD and bronchiectasis diagnosed by CT image before age 40
- •? Subject with severe COPD
- •?Subject requiring home O2 or Noninvasive Mechanical Ventilation
- •?Subject with a history of hypersensitivity to any component of the vaccine
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