NCT01070524已完成2 期
A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Trough FEV1 (mean 23h-24h FEV1)
研究概览
简要总结
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma
详细描述
A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe asthma partly controlled with ICS or ICS/LABA
- •FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value
排除标准
- •Diagnosis of COPD
- •History or current evidence of significant cardiovascular disease
- •Uncontrolled concomitant disease
研究组 & 干预措施
CHF 5188 pMDI
Experimental
干预措施: CHF 5188 pMDI (Drug)
Budesonide extrafine pMDI
Active Comparator
干预措施: Budesonide extrafine pMDI (Drug)
Seretide(r) Evohaler(r)
Active Comparator
干预措施: Seretide(r) Evohaler(r) (Drug)
结局指标
主要结局
Trough FEV1 (mean 23h-24h FEV1)
时间窗: after day 28 dose
次要结局
- Peak FEV1 and FVC(on day 1 and day 28)
- Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)(after day 1 dose)
- Trough FVC (mean 23-24h)(after day 28 dose)
- FEV1 AUC0-24(after day 1 and day 28)
研究者
研究点 (1)
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