EUCTR2011-002523-17-BG进行中（未招募）不适用
A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy, Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 µg Twice Daily Compared With Symbiort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 µg Twice Daily and Budesonide AC pMDI 2x160 µg Twice Daily in Adult and Adolescent Asthmatics - BAI (Breath Actuated Inhaler) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female 12 years and above
- •Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
- •Pre-bronchodilator FEV1 = 45 % and = 85% of predicted normal
- •Patients with reversible airway obstruction
- •Documented daily use of inhaled corticosteroids for = 3 months
- •Are the trial subjects under 18? yes
- •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 283
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •History of life-threatening asthma, defined for this protocol as an asthma episode tht required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures during the 2 years prior to Visit 2
- •Hospitalized during previous 6 months for asthma
- •Required emergency treatment more than once during previous 6 months for an asthma-related condition
- •Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrollment
- •Respiratory infection affecting asthma within 30 days
研究者
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