EUCTR2009-016757-18-IT进行中（未招募）不适用
A phase III, 12-week, multicentre, multinational, randomised, double-blind, double-dummy, 3 arm-parallel group study to test the efficacy of CHF 1535 50/6 microg (fixed combination of beclomethasone dipropionate plus formoterol fumarate) versus a free combination of beclomethasone dipropionate 50 microg plus formoterol fumarate 6 microg and versus a monotherapy of beclomethasone dipropionate 50 microg in partly controlled asthmatic children
CHIESI0 个研究点目标入组 1,000 人开始时间: 2012年2月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
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. Written informed consent obtained from the parents/legal representatives (according to the local regulation) and written or verbal assent by the patient (when appropriate) prior to any study related procedures. 2. Prepuberal male and female outpatients, aged = 5 and < 12 years in Tanner stages I and II according to Investigator's assessment. 3. Clinical diagnosis of asthma (GINA revised 2009) at least six months prior to screening visit. 4. Evidence of ''partly controlled'' asthma during the 2-week run-inperiod defined as following (GINA revised 2009), i.e. at least one of the following: - daytime symptoms more than twice/week, - any limitations of activities, - any nocturnal symptoms / awakening, - need for reliever/rescue treatment more than twice a week. 5. Treated with inhaled ß2-agonists as required. 6. Symptomatic asthmatic patients treated with inhaled beclomethasone dipropionate (BDP) up to 400 µg or equivalent at a stable dose for at least 4 weeks prior to screening visit. Equivalence to: BDP non-extrafine = 400 µg BDP extrafine = 200 µg Budesonide = 400 µg Ciclesonide = 320 µg Flunisolide = 1250 µg Fluticasone = 500 µg Mometasone = 400 µg Triamcinolone =1200 µg Patients under combination ICS-LABA or ICS-LTRA can enter into the study at the corresponding ICS dose, according to GINA guidelines (i.e. maximum 200 µg of non-extrafine BDP or equivalent). 7. A documented positive response to the reversibility test, defined as ?FEV1 = 12% over baseline, 15 minutes after 400 µg salbutamol pMDI via a Volumatic™ spacer device (ATS/ERS taskforce 2005) within 6 months prior to the screening must be provided. If not available, this test must be done at screening. 8. Forced Expiratory Volume during the first second (FEV1) = 60% and = 95% of predicted normal values at the screening visit and at the randomisation visit. 9. A cooperative attitude/ability and physical capacity to use a pMDI and a spacer device and perform lung functions.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 700
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever. 2. Any concomitant disease requiring additional treatment with systemic glucocorticosteroids. 3. Regular use of anticholinergics. 4. Allergy to one component of medications used. 5. Intolerance or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids. 6. Having received an investigational drug within 2 months before the current study. 7. Patients and/or parents unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments. 8. Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks preceding the screening visit or during the runin period. 9. History of cystic fibrosis, bronchiectasis, primary ciliary dyskinesia, bronchopulmonary dysplasia, or previous premature children with less than 36 weeks of gestational age. 10. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit). 11. Diagnosis of restrictive lung disease. 12. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion. 13. QTc interval (Fridericia's formula) higher than 450 msec (for boys)and 470 msec (for girls) at screening visit and randomisation visit. 14. Current smokers.
研究者
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