EUCTR2012-005586-13-GR进行中（未招募）不适用
A prospective, multicentre, randomised, double-blind, placebo-controlled, phase 2a study to compare the efficacy and the safety of 24-week treatment with masitinib versus placebo in patients with severe Chronic Obstructive Pulmonary Disease (COPD)
AB Science0 个研究点目标入组 45 人开始时间: 2015年12月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •1. Patient with history of chronic obstructive pulmonary disease for at least 12 months prior to screening visit (ATS/ERS 2005) and chronic productive cough for 3 months in each of the 2 years prior to screening visit (if other causes of productive cough have been excluded), and present during the 4 weeks preceding screening.
- •2. Patient with elevated eosinophils levels : >= 150/?L
- •3. Patient with at least one exacerbation during the preceding year.
- •4. Patient with FEV1/FVC ratio (post-bronchodilator) ? 70%.
- •5. Patient with FEV1 (post-bronchodilator) between = 30 % and ? 50 % of predicted value
- •6. Patient pre-treated with adequate and stable symptomatic treatment for at least 3 months prior to screening visit.
- •7. Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years
- •8. Patient with normal organ function defined as:
- •absolute neutrophils count (ANC) = 2.0 x 109/L,
- •haemoglobin = 10 g/dL
- •platelets (PTL) = 100 x 109/L
- •AST/ALT = 3x ULN
- •ßilirubin = 1.5x ULN
- •creatinin clearance > 60 mL/min
- •albumin > 1 x LLN
- •Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours.
- •9. Male or female patient, aged 40 to 75 years inclusive, weight > 50 kg and BMI between 18 and 35 kg/m²
- •10. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. ?hese include:
- •A documented placement of an intrauterine device (IUD) or system (IUS) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository)
- •Documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used
- •Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •Any other contraceptive method with a documented failure rate of <1% per year
- •Abstinence
- •11. Male patients must use medically acceptable methods of contraception if your female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug. These include:
- •If you have undergone surgical sterilization (vasectomy with documentation of azoospermia) a condom should also be used.
- •Male patients must use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. These are:
- •Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- •Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);
- •Your female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method
排除标准
- •1. Pregnant, or nursing female patient
- •2. Patient experiencing COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the screening visit.
- •3. Patient with lower respiratory tract infection not resolved 4 weeks prior to the screening visit.
- •4. Patient with 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).
- •5. Patient currently participating in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the screening visit.
- •6. Patients with known alpha-1-antitrypsin deficiency.
- •7. Patient with clinically significant cardiopulmonary abnormalities (diagnosed clinically or by X-ray / CT-scan / ECG) that are not related to COPD and that require further evaluation.
- •8. Patient who had major surgery within 2 weeks prior to screening visit
- •9. Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •Patient with cardiac failure class III or IV of the NYHA classification
- •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •Syncope without known aetiology within 3 months
- •Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
- •10. Patient with:
- •Life expectancy < 6 months
- •< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ
- •Any severe and/or uncontrolled medical condition
- •Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection, tuberculosis...)
- •11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
- •12. Treatment with any investigational agent within 4 weeks prior baseline
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