TCTR20161129004尚未招募3 期
A prospective, multicenter, randomised, double-blind, placebo-controlled, phase 3 study to compare the efficacy and the safety of masitinib versus placebo in the treatment of patients with severe uncontrolled asthma and elevated eosinophil levels
AB Science0 个研究点目标入组 345 人开始时间: 2016年11月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 345
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Patients with a physician diagnosis of persistent asthma for at least 12 months based on Global Initiative for Asthma (GINA) 2009 Guidelines whose asthma is partially controlled or uncontrolled on ICS/LABA combination therapy based on the following criteria:
- •â€¢ A well-documented requirement for regular treatment with a minimum dose of either fluticasone/salmeterol combination therapy (DPI formulation: 500/50 μg BID or MDI formulation: 460/42 μg BID), or budesonide/formoterol combination therapy (320/9 μg BID), or mometasone/formoterol combination therapy (400/10 μg BID) in the 12 months prior to screening with or without maintenance oral corticosteroids (OCS)
- •â€¢ Forced expiratory volume (FEV1) ≥ 50% predicted normal during the screening phase (3 attempts maximum) and on the randomization day prior to the first dose of IMP (3 attempts maximum)
- •â€¢ Reversibility of at least 12% and 200 ml in FEV1 after 200 μg to 400 μg (2 to 4 inhalations) of albuterol during the screening phase (3 attempts maximum), or documented history of a reversibility test that met this criteria within 12 months prior to screening, or documented history of bronchial hyperreactivity from a positive methacholine challenge (PD20 methacholine ≤ 8 mg) within 12 months prior to screening
- •â€¢ Within the 12 months prior to screening at least 2 severe asthma exacerbations while treated with stable dose for at least 2 weeks of either fluticasone/salmeterol combination therapy (DPI formulation: 500/50 μg BID or MDI formulation: 460/42 μg BID), or budesonide/formoterol combination therapy (320/9 μg BID), or mometasone/formoterol combination therapy (400/10 μg BID).
- •Severe asthma exacerbation is defined by any of the following events:
- •- Treatment with 1 or more systemic (oral and/or parenteral) steroid bursts for worsening asthma
- •- In-patient hospitalization or an emergency care visit for worsening asthma
- •2. Patient with elevated eosinophil level related to asthma at baseline: >= 0.15 K/uL or patient with eosinophil level >= 0.15 K/uL related to asthma demonstrated in the year prior to screening
- •3. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs/year
- •4. Patient with normal organ function defined as:
- •â€¢ Absolute neutrophil count (ANC) ≥ 2.0 x 109/L
- •â€¢ Haemoglobin ≥ 10 g/dL
- •â€¢ Platelets (PTL) ≥ 100 x 109/L
- •â€¢ AST and ALT ≤ 3 x ULN
- •â€¢ Bilirubin ≤ 1.5x ULN
- •â€¢ Creatinine clearance > 60 mL/min (Cockcroft and Gault formula)
- •â€¢ Albuminemia > 1 LLN
- •â€¢ Proteinuria < 30 mg/dL on the dipstick (1+). In case of proteinuria ≥ 30 mg/dL (1+ on the dispstick) , 24 hours proteinuria must be < 1.5g/24 hours
- •5. Male or female patient aged 18 to 75 years
- •6. Patient weight > 41 kg and Body Mass Index (BMI) between 18 and 35 kg/m²
- •7. Contraception:
- •â€¢ Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake.
- •â€¢ Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake OR who agrees to use an
排除标准
- •1. Female patient who is pregnant or lactating
- •2. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
- •3. Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests
- •4. Within 12 weeks prior to screening, patient who received oral corticosteroids for any other reason than to treat severe asthma exacerbation (patients needing long term corticosteroids intake to control basal asthma condition)
- •5. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
- •6. Patient presenting with cardiac disorders defined by at least one of the following conditions will be excluded:
- •a. Patient with recent cardiac history (within 6 months) of:
- •i. Acute coronary syndrome
- •ii. Acute heart failure (class III or IV of the NYHA classification)
- •iii. Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •b. Patient with cardiac failure class III or IV of the NYHA classification
- •c. Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •d. Syncope without known aetiology within 3 months
- •e. Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
- •7. Patient with active lung disease other than asthma (e.g. chronic bronchitis)
- •8. Patient who had a major surgery within 2 weeks prior to screening visit
- •9. Patient with life expectancy < 6 months
- •10. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
- •11. Patient with any severe and/or uncontrolled medical condition
- •12. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection
- •13. 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
- •14. Patient treated with prohibited medication or inadequate wash-out time at the screening visit:
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