NCT01475032已完成3 期
A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children
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
- 638
- 试验地点
- 11
- 主要终点
- pre-dose FEV1 (forced expiratory volume in the first second)
研究概览
简要总结
The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.
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
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children (aged ≥ 5 and < 12 years)
- •Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)
- •Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent
- •FEV1 ≥ 60% and ≤ 95% of predicted normal values
排除标准
- •Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
- •Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry
- •History of near fatal asthma
- •History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia
- •Diagnosis of restrictive lung disease.
- •Patients treated with systemic corticosteroids
- •Significant medical history and/or treatments
研究组 & 干预措施
CHF 1535
Experimental
CHF 1535 (BDP/FF) for 12 weeks
干预措施: CHF 1535 (Drug)
BDP
Active Comparator
BDP for 12 weeks
干预措施: Beclomethasone (BDP) (Drug)
BDP+FF
Active Comparator
free combo BDP+FF for 12 weeks
干预措施: Beclomethasone (BDP) + Formoterol Fumarate (FF) (Drug)
结局指标
主要结局
pre-dose FEV1 (forced expiratory volume in the first second)
时间窗: 12 weeks
Assessment of lung function parameter as pre-dose FEV1
次要结局
- Rescue medication use(12 weeks)
- Patient with Asthma symptoms(12 weeks)
- Number of patients with adverse events(12 weeks)
- Blood parameters(at week 0 and week 12)
- Blood pressure(12 weeks)
- FVC (forced vital capacity)(12 weeks)
- PEF (peak expiratory flow)(12 weeks)
- Heart rate(12 weeks)
研究者
研究点 (11)
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