CTRI/2011/11/002122暂停3 期
A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 studyto compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment ofpatients with Severe Persistent Asthma treated with oral corticosteroids
AB Science0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 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
入排标准
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 ³ 35 to £ 80% of the predicted normal value, demonstrated at least 6 hours after
- •short-acting b-2-agonist or 12 hours after long-acting b-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 symptoms More than twice/week
- •Limitations of activities symptoms Any
- •Nocturnal symptoms/awakening Any
- •Need for reliever/rescue treatment More than twice/week
- •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:
- •Â· Absolute neutrophil count (ANC) >= 2.0 x 109/L
- •Â· Haemoglobin >= 10 g/dL
- •Â· Platelets (PTL) >= 100 x 109/L
- •Â· AST/ALT <= 2.5x ULN
- •Â· Bilirubin <= 1.5x ULN
- •Â· Creatinine clearance >= 50 mL/min (Cockcroft and Gault formula)
- •Â· Albumin > 1 LLN
- •Â· Urea <= 1.5 x ULN
- •Â· 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
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
- •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 (atrioventricular
- •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
- •Â· Long acting Beta agonists (12h prior to screening visit)
- •Â· Short acting agonists (6h prior to screening visit)
- •13. Patient treated with prohibited medications
- •14. Patient with known hypersensitivity to Cetirizine.
研究者
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