EUCTR2004-000288-89-ES进行中（未招募）1 期
A 24 week, double blind, randomized study to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo on parameters indicative of hyperinflation in patients with chronic obstructive pulmonary disease - HERO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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
- •- Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD criteria (2003)
- •- Age more than 40 years
- •- FEV1/FVC ratio (post-bronchodilator) < or = 70%
- •- FEV1 (post-bronchodilator) < or = 65% of predicted
- •- FRC (post-bronchodilator) > or = 120% of predicted
- •- Clinically stable COPD within 4 weeks prior to baseline visit B0
- •- Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed at visit B0
- •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 not stopped at least 4 weeks prior to the baseline visit B0
- •- Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years (1 One pack year is defined as 20 cigarettes/day for 1 year)
- •- Suffering from any concomitant disease that might interfere with study procedures or evaluation
- •- Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit B0
- •- 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)
- •- Known infection with HIV, active hepatitis and/or liver insufficiency
- •- Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
- •- Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray / ECG) that are not related to COPD and that require further evaluation
- •- Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
- •- Participation in another study (use of investigational product) within 30 days preceding the baseline visit B0 or re-entry of patients already enrolled in this trial
- •- Alcohol or drug abuse
- •- Suspected hypersensitivity to the study medication and/ or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
- •- known alpha-I-antitrypsin deficiency
研究者
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