EUCTR2004-004442-40-ES进行中（未招募）1 期
500µg roflumilast once daily in combination with 50µg salmeterol twice daily versus 50µg salmeterol twice daily alone over 52 weeks in patients with COPD. - ROCKET
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 876
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
- •- Given written informed consent
- •- Age > or = 40 years
- •- Patients with a history of moderate or severe chronic obstructive pulmonary disease for at least 12 months prior to baseline visit V0 as defined by the GOLD criteria (2003)
- •- FEV1/FVC ratio (post-bronchodilator) < 70%
- •- FEV1 (post-bronchodilator) < or = 60% of predicted
- •- Fixed airway obstruction (defined as an FEV1 increase of < or = 15% and/or < or = 200 ml after receiving 400 µg salbutamol)
- •- At least one moderate or severe COPD exacerbation (as defined by the need for systemic glucocorticosteroid and/or antibiotics intake) 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 10 pack years
- •- Availability of a chest x-ray 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 6 months preceding the baseline visit V0
- •- Known alpha-1-antitrypsin deficiency
- •- Need for long-term oxygen therapy defined as = 16 hours/day
- •- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
- •- Known infection with HIV, active hepatitis and/or liver insufficiency
- •- 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 / 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 > 1 year 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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