EUCTR2005-005080-28-GB进行中（未招募）1 期
Effect of roflumilast in COPD patients treated with salmeterol. A 24 week, double blind study with 500 mcg roflumilast once daily versus placebo - EOS
ycomed GmbH0 个研究点目标入组 938 人开始时间: 2006年3月10日最近更新:
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
- 938
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
- •· Written informed consent
- •· Age > or = 40 years
- •· History of chronic obstructive pulmonary disease for at least 12 months prior to baseline visit V0 (ATS/ERS 2005)
- •· FEV1/FVC ratio (post-bronchodilator) < or = 70%
- •· FEV1 (post-bronchodilator) between > or = 40% and < or = 70% of predicted
- •· Fixed airway obstruction (defined as an FEV1 increase of < or = 12% or < or = 200 ml after receiving 400 µg salbutamol)
- •· Not suffering from any concomitant disease that might interfere with study procedures or evaluation
- •· Current smoker with a smoking history of at least 10 pack years OR
- •· Former smoker (defined as: smoking cessation at least one year ago) that has a smoking history of at least 10 pack years
- •· Availability of a chest x-ray or CT scan dated a maximum of 6 months prior to study baseline visit V0 or willingness to have a chest x-ray performed at visit V0
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the baseline visit V0
- •· Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
- •· 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], and active tuberculosis)
- •· Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
- •· Known alpha-1-antitrypsin deficiency
- •· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
- •· Known infection with HIV and/or active hepatitis
- •· Diagnosis or history of cancer (other than basal cell carcinoma) within 5 years prior to study start
- •· Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray / CT-scan / ECG) that are not related to COPD and that require further evaluation
- •· Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
- •· Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or post-menopausal > 2 years or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases
- •· Participation in another study (use of investigational product) within 30 days preceding the baseline visit V0 or re-entry of patients already enrolled in this trial
- •· Suspected inability or unwillingness to comply with study procedures
- •· Alcohol or drug abuse
- •· Inability to follow study procedures due to e.g. language problems, psychological disorders
- •· Use of not allowed drugs
- •· Suspected hypersensitivity to the study medication (roflumilast or salmeterol) or rescue medication, or any other contraindication for the use of salmeterol
研究者
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