NCT00255255已完成3 期
An Open, Phase III, Multicentre, 52-week Study, Evaluating the Safety and Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 18
- 主要终点
- Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate
研究概览
简要总结
This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
- •Prescribed daily use of an IGCS for ≥12 weeks prior to Visit 1
- •Prescribed daily use of at least one of the following:
- •Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose
排除标准
- •Any significant disease or disorder that may jeopardize the safety of the patient
- •Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
- •Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
结局指标
主要结局
Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate
次要结局
- Forced expiratory volume in one second (FEV1)
- Patient reported outcomes regarding disease status (incl. PEF), collected via diaries
- - all variables assessed over the 52 week treatment period
研究者
研究点 (18)
Loading locations...
相似试验
已完成
3 期
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in JapanChronic Obstructive Pulmonary DiseaseNCT01070784AstraZeneca328
已完成
不适用
Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever TherapyBronchial AsthmaNCT01711840AstraZeneca2,409
已完成
3 期
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mgAsthmaNCT00242775AstraZeneca2,100
进行中（未招募）
1 期
Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month randomised, double-blind, parallel-group, active controlled, multinational phase IIIB study in adult and adolescent patients with persistent asthma. - AHEADThis is a Phase IIIB study to be performed in adult and adolescent asthmatic patients.Classification code 10003553EUCTR2004-004905-11-ESAstraZeneca AB2,309
进行中（未招募）
不适用
Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month randomised, double-blind, parallel-group, active controlled, multinational phase IIIB study in adult and adolescent patients with persistent asthma. - AHEADThis is a Phase IIIB study to be performed in adult and adolescent asthmatic patients.Classification code 10003553EUCTR2004-004905-11-DEAstraZeneca AB2,300