Multicentre, multinational, randomised, double blind, double dummy, active drug controlled, parallel group study design clinical trial of the efficacy and tolerability of beclomethasone dipropionate 250 mcg plus salbutamol 100 mcg in HFA pMDI fixed combination vs. beclomethasone dipropionate 250 mcg plus salbutamol 100 mcg in CFC pMDI (Clenil Compositum 250) fixed combination in a 12-week treatment period of adult patients with uncontrolled asthma - ND

CHIESI0 个研究点目标入组 282 人开始时间: 2007年7月13日最近更新: 2012年3月19日

试验速览

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•1. Written informed consent obtained, 2. Male or female out-patients aged ? 18 and < 65 years; 3. Uncontrolled asthma defined according to the GINA 2006 ?Classification of Levels of Asthma Control?. This definition includes the presence of two or more of the following features (in addition to the required range of FEV1): a) daytime asthma symptoms > twice a week; b) any limitation of activities; c) any nocturnal symptoms/awakening; b) need for reliever/rescue treatment > twice a week. These conditions are to be based on recent medical history and are to be confirmed in the 2-week run-in period;4. Forced expiratory volume in the first second (FEV1) ? 60% and < 80% of the predicted normal value;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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. Inability to carry out pulmonary function testing;2. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines updated 2006;3. History of near fatal asthma;4. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks;5. Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;6. Patients who have been treated with an inhaled corticosteroid in the previous 4 weeks;7. Patients who have been treated with nebulized, oral, intravenous or intramuscular corticosteroids in the past 8 weeks or depot injectable corticosteroids in the past 12 weeks;8. Patients who have been treated with a long-acting β2-agonist (LABA) in the past 2 weeks;

发起方

CHIESI