NCT01577082已完成3 期
A 12-week, Multinational, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of CHF 1535 200/6µg Versus Beclomethasone Dipropionate in Adult Asthmatic Patients Not Adequately Controlled on High Dose of Inhaled Corticosteroids or on Medium Dose of Inhaled Corticosteroids Plus Long-acting β2 Agonists
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
- 542
- 试验地点
- 1
- 主要终点
- Pre-dose morning PEF
研究概览
简要总结
The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA pMDI in terms of lung function considering change from baseline to the entire treatment period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled on high doses of ICS or on medium dose of ICS+LABA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged > 18 years.
- •Patients with persistent asthma not optimally controlled (GINA 2010) on high doses of ICS or medium dose of ICS+LABA at a stable dose for at least 4 weeks prior to screening.
- •Patients with FEV1 >= 40% and < 80% of predicted for the patient normal value and at least 0.9 L.
- •Patients with a documented positive response to the reversibility test, defined as ΔFEV1 >= 12% and >= 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI.
- •At screening and at the end of the run-in period, patients with not adequately controlled asthma according to GINA 2010 and with score at the Asthma Control Questionnaire (ACQ)> 0.75
排除标准
- •History of near fatal asthma or of a past hospitalisation for asthma in Intensive Care Unit or of frequent exacerbations (3 or more asthma exacerbations/ year).
- •Hospitalisation, Emergency Room admission or use of systemic steroids (more than 3 days) for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period.
- •Symptomatic infection of the lower airways in the 4 weeks before the screening visit.
- •Current or ex-smokers with total cumulative exposure equal or more than 5 pack-years and /or having stopped smoking one year or less prior to screening visit.
- •Patients with a clinically significant abnormality at 12-lead ECG or presenting a QTcB interval value in ECG > 450 msec in males or > 470 msec in females).
研究组 & 干预措施
CHF 1535 200/6µg
Experimental
干预措施: CHF1535 200/6 µg (Drug)
BDP 100µg
Active Comparator
干预措施: BDP 100 µg (Drug)
结局指标
主要结局
Pre-dose morning PEF
时间窗: 12 weeks
Change from baseline to the entire treatment period in average pre-dose morning PEF
次要结局
- Asthma symptoms(12 weeks)
- Adverse Events(14 weeks)
- Pre-dose morning FEV1(2 weeks)
研究者
研究点 (1)
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