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临床试验/EUCTR2010-020803-63-GR
EUCTR2010-020803-63-GR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: 2013年11月25日最近更新:
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适应症

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
研究概览入排标准研究者记录与标识符相似试验

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 treatmentMore 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
  • •7. Male or female patient older than 18 years
  • •8. Patient weight > 45 kg and Body Mass Index (BMI) > 18 kg/m²
  • •9. 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
  • •10. Patient able and willing to comply with study procedures as per protocol
  • •11. 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.
  • •12. 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 250
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 50

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:
  • •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.

研究者

发起方
AB Science

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