A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting ß2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (=12 years of age) patients with asthma.

AstraZeneca AB0 个研究点目标入组 12,460 人开始时间: 2011年12月19日最近更新: 2022年1月24日

研究概览

暂无简介。

•1. Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
•2. Male or Female, =12 years of age
•3. Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
•4. Patient must have history of at least 1 asthma exacerbation including one of the following:
•- requiring treatment with systemic corticosteroids
•- an asthma-related hospitalization between 4 weeks and 12 months
•prior to randomization
•5. Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire
•6. Availability and ability to perform the necessary manoeuvres and
•procedures required by the study (eg, read the ACQ6 questionnaire, use a pMDI, perform daily telephone calls)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1287
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9594
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 819

•1. Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
•2. Patient has required treatment with systemic corticosteroids tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
•3. Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids(tablets, suspension, or injectable)
•4. An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
•5. Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator’s opinion, will interfere with the patient’s lung function
•6. Patient ust not meet unstable asthma severity criteria as listed in the protocol.
•7. Peak expiratory flow must not be below 50% of predicted normal.
•8. Pregnancy, breast-feeding or planned pregnancy during the study.

发起方