NCT00288379已完成3 期
A Comparative, Placebo-controlled, Double Blind, Double Dummy, Cross-over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-dose Allergen Challenge in Allergic Patients With Mild 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
- 16
- 试验地点
- 1
- 主要终点
- PD20 methacholine (measured as the change using the measurement before and after each treatment period).
研究概览
简要总结
To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosed history of asthma for at least 6 months
- •Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
- •FEV1 >70% of predicted normal value (post-bronchodilator value).
- •Skin prick test positive to pollen, animal dander or house dust mite.
排除标准
- •Any significant respiratory disease, other than asthma.
- •Upper or lower respiratory tract infection within 4 weeks before inclusion.
- •inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
- •inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
- •regular NSAIDs
结局指标
主要结局
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
次要结局
- Discontinuation due to Adverse Events (DAEs).
- eNO (ppb).
- Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
- Total and differential blood cell count
- Different Biomarkers
- Safety endpoints will be incidence of Serious Adverse Events (SAEs)
研究者
研究点 (1)
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