EUCTR2005-003937-42-GB进行中（未招募）1 期
Effect of roflumilast on exacerbation rate in patients with COPD A 52 weeks, double-blind study with 500 mcg roflumilast once daily versus placebo - AURA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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 COPD for at least 12 months as defined in the ATS/ERS consensus statement (Standards for the Diagnosis and Management of patients with COPD, 2004) and chronic productive cough for 3 months in each of the 2 years prior to baseline visit V0 (if other causes of productive cough have been excluded)
- •· FEV1/FVC ratio (post-bronchodilator) < or= 70%
- •· FEV1 (post-bronchodilator) < or = 50% of predicted
- •· At least one documented COPD exacerbation (as defined by the need for oral or parenteral glucocorticosteroid intake and/or hospitalization) within one year prior to study baseline visit V0
- •· Not suffering from any concomitant disease that might interfere with study procedures or evaluation
- •· Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 20 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 or CT-scan 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 oral or parenteral glucocorticosteroids and/or hospitalization not resolved at 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)
- •· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
- •· 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 > 1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases
- •· Chronic gastrointestinal disorders associated with a history of recurrent gastrointestinal bleedings within the last 12 months preceding the baseline visit V0
- •· Participation in another clinical study (use of investigational product) within 30 days preceding the baseline visit V0
- •· Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
- •· Use of disallowed drugs
- •· Use of immunosuppressive medications within 4 weeks prior to baseline (e.g. cyclosporine, methotrexate, TNF alpha receptors or antibodies, gold, azothiaprine)
- •· Known alpha-1-antitrypsin deficiency
- •· Known infection with HIV and/or active hepatitis
- •· Diagnosis, treatment, or remission of any cancer (other than basal cell carcinoma) within 5 years prior to study start,
- •· Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/CT-scans/ ECG) that are not related to COPD and that require further evaluation
- •· Clinically relevant ECG findings (e.g. acute or recent myocardial infarction, clinically significant arrhythmia)
- •· Alcohol or drug abuse
- •· Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
- •· Patients not able to follow study procedures e.g. language problems, psychological disorders
- •· Suspected non-compliance
研究者
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