EUCTR2011-002905-31-GB进行中（未招募）1 期
Effect of roflumilast 500 µg tablets once daily at acute COPD exacerbations treated with standard therapy of oral steroids and antibiotics. A randomised, double-blind, placebo-controlled, parallel-group trial. - TREAT
ycomed GmbH0 个研究点目标入组 81 人开始时间: 2011年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 81
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
入选标准
- •I1. Written informed consent (IC);
- •I2. Age =40 years;
- •I3. History of COPD for at least 12 months prior to enrolment (Visit V0);
- •I4. Chronic productive cough for 3 months in each of the 2 years prior to enrolment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrolment;
- •I5. Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour;
- •I6. Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) <70% (if a pulmonary function test is not possible at Visit V0 a previous measurement can be taken which must not be older than 6 months);
- •I7. Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 10 pack years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •E1. Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis] or active tuberculosis);
- •E2. Known a-1-antitrypsin deficiency;
- •E3. Recurrent exacerbations (within 8 weeks of a preceding exacerbation);
- •E4. Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrolment;
- •E5. Treatment with PDE4 inhibitors within 3 months prior to Visit V0;
- •Criteria within ethical considerations in terms of general health:
- •E6. Oxygen therapy (more than 8 hours daily);
- •E7. Formal contraindications to sputum collection or impossibility to obtain a sample of sputum valid for analysis;
- •E8. Respiratory failure when presenting at Visit V0;
- •E9. Severe psychiatric or neurological disorders;
- •E10. History of depression associated with suicidal ideation or behaviour;
- •E11. Congestive heart failure severity grade IV according to the New York Heart Association Functional Classification;
- •E12. Haemodynamically significant cardiac arrhythmias or heart valve deformations;
- •E13. Immunological diseases or known infection with human immunodeficiency virus;
- •E14. Liver impairment Child-Pugh B and C and/or active viral hepatitis;
- •E15. Severe acute infectious diseases;
- •E16. Any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) within 5 years before trial start;
- •E17. Alcohol or drug abuse within the past year;
- •E18. Suspected hypersensitivity to the IMP or ingredients thereof, or any other contraindication for the use thereof;
- •E19. Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire trial duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilised/hysterectomised or post-menopausal >1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases;
- •E20. Pregnancy, breast feeding, planned oocyte donation or oocyte implantation;
- •E21. Planned donation of germ cells, blood, organs or bone marrow during the course of the trial;
- •E22. Participation in another trial (use of investigational product) within 30 days of Visit V0 or re-entry of patients previously enroled in this trial;
- •E23. Suspected inability or unwillingness to comply with trial procedures (e.g. language problems, psychological disorders);
- •E24. Suffering from any concomitant disease that might interfere with trial procedures or evaluations;
- •E25. Use of disallowed drugs (see Section 6.8);
- •E26. Employee at the trial site, relative or spouse of the investigator.
研究者
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