EUCTR2009-016757-18-ES进行中（未招募）1 期
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 ?g (fixed combination of beclomethasone dipropionate plus formoterol fumarate) versus a free combination of beclomethasone dipropionate 50 ?g plus formoterol fumarate 6 ?g and versus a monotherapy of beclomethasone dipropionate 50 ?g in partly controlled asthmatic children
Chesi Farmaceutici SpA0 个研究点目标入组 638 人开始时间: 2011年9月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 638
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.
- •For France: only patients registered under a social welfare can be included in the study.
- •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-in period 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 ?2-agonists as required.
- •6. Symptomatic asthmatic patients treated with inhaled beclomethasone dipropionate (BDP) up to 400 ?g or equivalent at a stable dose for at least 4 weeks prior to screening visit.
- •Equivalence to:
- •BDP non-extrafine ? 400 ?g
- •BDP extrafine ? 200 ?g
- •Budesonide ? 400 ?g
- •Ciclesonide ? 320 ?g
- •Flunisolide ? 1250 ?g
- •Fluticasone ? 500 ?g
- •Mometasone ? 400 ?g
- •Triamcinolone ?1200 ?g
- •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 ?g 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 ?g 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 ?2-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 run-in 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.
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