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 SymbicortÂ®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting Î²2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (more or equal 12 Years of Age) Patients With Asthma

AstraZeneca AB0 个研究点目标入组 428 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
•Male or Female,more or equal 12 years of age
•Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
•Patient must have history of at least 1 asthma exacerbation including one of the following:
•orequiring treatment with systemic corticosteroids
•oan asthma-related hospitalization between 4 weeks and 12 months prior to randomization
•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

•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.
•Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
•Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
•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
•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 investigators opinion, will interfere with the patients lung function
•Patient must not meet unstable asthma severity criteria as listed in the protocol
•Peak expiratory flow must not be below 50% o predicted normal
•Pregnancy, breast-feeding or planned pregnancy during the study

发起方