A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE) AND THE FREE COMBINATION OF LICENSED BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ASTHMATIC CHILDREN ALREADY TREATED WITH INHALED CORTICOSTEROIDS

Chiesi Farmaceutici S.p.A.0 个研究点目标入组 60 人开始时间: 2011年6月14日最近更新: 2016年8月8日

试验速览

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•1.Prepuberal male and female outpatients, = 5 and < 12 years old in Tanner stadium I according to Investigator's assessment;
•2.Written informed consent by parents/legal representatives;
•3.Clinical diagnosis of mild asthma during at least two months prior to screening visit;
•4.Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit;
•5.Treated with inhaled ß2-agonists used as rescue medicaton and or beclomethasone up to 400µg daily or equivalent treatments;
•6.Compliant to study procedures and able to visit the centre for controls as reported into the protocol. A cooperative attitude and ability to be trained in the proper use of a pMDI and spacers.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•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

•1.Male and female out patients in Tanner stadium II-V;
•2.Endocrinological diseases including growth impairment or other chronic diseases;
•3.Known sensitivity to the components of study medication;
•4.Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;
•5.Allergy to one component of medications used;
•6.Intolerance or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids;
•7.Having received an investigational drug within 2 months before the current study;
•8.Patient’s participation in another clinical trial in parallel with the present study;
•9.Inability to perform outcome measurements optimally and to complete diary cards

发起方