An Open, Randomised, Parallel Group Multi-centre, Methodology Study, Evaluating the Sensitivity of Oxygen-Enhanced Magnetic Resonance Imaging (OE-MRI) in Detecting and Comparing Response to 8 Weeks Treatment With Budesonide/Formoterol Turbuhaler® (320/9 µg Bid) and Formoterol Turbuhaler® (9 µg Bid) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Oxygen enhanced MRI V4
研究概览
简要总结
The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 40 years
- •Male and female
- •Clinical diagnosis of moderate to severe COPD according GOLD guidelines
- •Current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years
- •A Modified Medical Research Council (MMRC) dyspnoea scale score of ≥
- •FEV1/FVC < 0.7 (post-bronchodilator)
- •FEV1 > 40 % PN and < 70 % PN (post-bronchodilator)
- •Clinical Study Protocol Local Amendment affects UK:
- •FEV1 > 30 % PN and < 80 % PN (post-bronchodilator)
排除标准
- •Current diagnosis of asthma according to GINA guidelines
- •Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
- •Significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1
- •Participation in or scheduled for an intensive COPD rehabilitation program
- •Claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other MRI contraindication such as obesity or inability to stay in the supine position for 60 minutes
研究组 & 干预措施
1
Single Dose evaluation placebo (V5)
干预措施: Formoterol Turbuhaler (Drug)
2
Single Dose evaluation formoterol (V5)
干预措施: Budesonide/Formoterol Turbuhaler (Drug)
2
Single Dose evaluation formoterol (V5)
干预措施: Formoterol Turbuhaler (Drug)
结局指标
主要结局
Oxygen enhanced MRI V4
时间窗: Visit 4
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Oxygen enhanced MRI V5
时间窗: Visit 5
Oxygen enhanced MRI parameters
Oxygen enhanced MRI V7
时间窗: Visit 7
Oxygen enhanced MRI parameters
次要结局
- Transferability of OE-MRI technique(10 months)
- OE-MRI variables(patients will fill in a patient diary at home between visit 2 and 7)
- Impulse oscillometry parameters V2(Visit 2)
- Impulse oscillometry parameters V4(Visit 4)
- Impulse oscillometry parameters V5(Visit 5)
- Impulse oscillometry parameters V7(Visit 7)