EUCTR2010-020803-63-DE进行中（未招募）不适用
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: 2011年9月21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
- 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 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
- •2. Patient treated during at least one period of 21 days with oral corticosteroids from one year prior to screening to 3 months before screening.
- •3. 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 ?-2-agonist or 12 hours after long-acting ?-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 as defined as two or more of the following features within the week prior to screening visit (ACQ items)
- •Daytime symptomsMore than twice/week
- •Limitations of activities symptomsAny
- •Nocturnal symptoms/awakening Any
- •Need for reliever/rescue treatment More than twice/week
- •4. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
- •5. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs/year
- •6. Patient with normal organ function defined as:
- •Absolute neutrophil count (ANC) = 2.0 x 109/L
- •Haemoglobin = 10 g/dL
- •Platelets (PTL) = 100 x 109/L
- •AST/ALT = 3 x ULN
- •Bilirubin = 1.5x ULN
- •Creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •Albumin > 1 LLN
- •Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
- •Patient with negative urine cytology and NMP22 protein assay
- •7. Male or female patient aged 18 to 75 years
- •8. Patient weight > 50 kg and Body Mass Index (BMI) between 18 and 35 kg/m²
- •9. 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.
- •10. 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.
- •11. Patient able and willing to comply with study procedures as per protocol
- •12. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.
- •13. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
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.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
- •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:
- •Long Acting Bronchodilators (12h prior to screening visit)
- •Short Acting Bronchodilators (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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