NCT00929851已完成3 期
a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,199
- 试验地点
- 1
- 主要终点
- Exacerbation rate Change in pre-dose FEV1
研究概览
简要总结
a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
详细描述
a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Severe COPD
- •At least one COPd exacerbation in previous year
排除标准
- •Asthma, allergic rhinitis or other atopic disease
- •Unstable concurrent disease:
- •Evidence of heart failure
研究组 & 干预措施
BDP/FF
Experimental
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler
干预措施: CHF1535 (Drug)
Formoterol fumarate
Active Comparator
Formoterol fumarate 12 µg per metered dose
干预措施: Formoterol fumarate (Drug)
结局指标
主要结局
Exacerbation rate Change in pre-dose FEV1
时间窗: 0-4-12-24-36-48 weeks
次要结局
- Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication(0-4-12-24-36-48 weeks)
研究者
研究点 (1)
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