EUCTR2010-020803-63-SK进行中（未招募）1 期
A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids
AB Science0 个研究点目标入组 300 人开始时间: 2013年4月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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 Severe Persistent Asthma and already treated with oral corticosteroids at a minimal daily dose of 5 mg prednisone or equivalent for at least 3 months prior to screening visit
- •2. Patient with history of asthma = 1 year prior to screening visit who also meet the following criteria:
- •o baseline FEV1 = 35 to = 80% of the predicted normal value, demonstrated at least 6 hours after short-acting beta-2-agonist or 12 hours after long-acting beta-2-agonist
- •o at least 2 asthma exacerbations within one year prior to screening visit including one severe asthma exacerbation as per protocol definition
- •o uncontrolled asthma
- •3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
- •4. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs/year
- •5. Patient with normal organ function defined as:
- •o Absolute neutrophil count (ANC) = 2.0 x 109/L
- •o Haemoglobin = 10 g/dL
- •o Platelets (PTL) = 100 x 109/L
- •o AST/ALT = 2.5x ULN
- •o Bilirubin = 1.5x ULN
- •o Creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •o Albumin > 1 LLN
- •o Urea = 1.5 x ULN
- •o Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
- •6. Male or female patient older than 18 years
- •7. Patient weight > 45 kg and BMI > 18 kg/m²
- •8. Male or female patient of child bearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two 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
- •9. Patient able and willing to comply with study procedures as per protocol;
- •10. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- •11. Patient affiliated to a social security regimen
- •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
- •1.Female patient who is pregnant or lactating
- •2.Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
- •3.Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
- •4.Patient presenting with cardiac disorders defined by at least one of the following conditions will be excluded:
- •a.Ischemic heart disease, defined by at least one of the following conditions:
- •i.Medical history of ischemic heart disease
- •ii.Clinical symptoms of ischemic heart disease
- •iii.Q wave > 3 mm on the electrocardiogram
- •iv.ST elevation or depression > 2 mm on the electrocardiogram
- •v.Negative T wave in at least 2 leads of the electrocardiogram
- •b.Cardiac failure, defined by at least one of the following conditions:
- •i.Medical history of cardiac failure defined by a previous left ventricular ejection fraction = 50%
- •ii.Clinical symptoms of cardiac failure
- •iii.Current treatment for cardiac failure
- •iv.NT Pro-BNP = 300 pg/mL or BNP = 75 pg/mL and/or troponin T > 0.1 ng/mL or troponin I > 0.35 ng/mL
- •c.Conduction disorders or arrhythmia, defined by at least one of the following and confirmed by electrocardiogram:
- •i.Severe ventricular arrhythmia (frequent premature ventricular beats)
- •ii.Atrioventricular block at second or third level
- •iii.Left bundle branch block
- •5.Patient with active lung disease other than asthma (e.g. chronic bronchitis)
- •6.Patient who had a major surgery within 2 weeks prior to screening visit
- •7.Patient with life expectancy < 6 months
- •8.Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
- •9.Patient with any severe and/or uncontrolled medical condition
- •10.Patient with a known diagnosis of human immunodeficiency virus (HIV) infection
- •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.Patient with inadequate wash-out time at the screening visit:
- •Wash-out time for prohibited concomitant asthma medications:
- •Treatment with the following non-steroidal controllers has to be stopped about 24 h prior to screening visit: sustained-release theophylline, leukotriene antagonists, lipoxygenase inhibitors, inhaled anticholinergics, oral beta2-agonists, inhaled disodium cromoglycate, inhaled nedocromil.
- •Wash-out time for allowed concomitant asthma medications
- •Long acting Beta agonists (12h prior to screening visit)
- •Short acting agonists (6h prior to screening visit)
- •13.Patient treated with prohibited medications
- •RANDOMISATION CRITERIA (to be checked at W0):
- •1.Good study treatment (i.e. placebo) compliance (=80%) during the 2-week run-in period
- •2.Daily mean symptom score = 2 during the 2-week run in period
- •3.No asthma exacerbation (moderate or severe) during the 2-week run in period
研究者
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