A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE 50 µg PLUS FORMOTEROL FUMARATE 6 µg ) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETASONE DPI AND FORMOTEROL DPI IN ASTHMATIC CHILDRE

Chiesi Farmaceutici S.p.A0 个研究点目标入组 26 人开始时间: 2011年8月31日最近更新: 2013年5月13日

试验速览

暂无简介。

•Patients will be eligible for enrolment if they meet all of the following criteria:
•1.Written informed consent obtained by Parent/Legal Representative (according to local regulation) and by the minor (age and local regulation permitting).
•2.Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments
•3.Male/female children with asthma receiving regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
•4.Age = 5 < 12 years (8 to 10 children in the age range 5-8 years old)
•5.Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding ?2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
•6.A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 26
•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

•Patients will not be enrolled if one or more of the following criteria are present:
•1.Past or present diagnosis of cardiovascular, renal or liver disease
•2.Known hypersensitivity to the active treatments
•3.Exacerbation of asthma symptoms within the previous 4 weeks
•4.Inability to perform the required breathing technique and blood sampling
•5.Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
•6.Lower respiratory tract infection within 1 month prior to screening (visit 1)
•7.Disease (other than asthma) which might influence the outcome of the study
•8.Obesity, i.e. > 97% weight percentile by local standards

发起方