A comparison of SymbicortÂ® Maintenance and Reliever Therapy (Symbicort TurbuhalerÂ® 160/4.5 mg, one inhalation bid plus as-needed) and Symbicort Turbuhaler 160/4.5 mg, one inhalation bid plus Terbutaline Turbuhaler 0.4 mg/inhalation as-needed, for treatment of asthma ? a 12-month, randomized, double-blind, parallel group, active-controlled, multinational, phase III study in asthmatic patients aged 16 years and above.

AstraZeneca R D0 个研究点目标入组 249 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Provision of signed and dated informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient?s parent/legal guardian is required.
•2.Outpatients of either gender aged >=16 years
•3.Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration prior to start of study
•4.FEV1 Â³ 50% of predicted normal value pre-bronchodilator
•5.Reversible airway obstruction defined as an increase in FEV1 >=12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline (delivered dose) Turbuhaler
•6.Prescribed use of inhaled GCS (any brand) for at least 12 weeks prior to Visit 2

•Patients must not enter the study if any of the following exclusion criteria are fulfilled.
•1.Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks prior to Visit 2
•2.Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks prior to Visit 2

发起方

AstraZeneca R D