NCT01848769已完成2 期
A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children
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
- 20
- 试验地点
- 1
- 主要终点
- B17MP AUC0-t
研究概览
简要总结
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
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
- None
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/Female children aged 5-11 years
- •Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
- •children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
- •Forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.
- •A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.
排除标准
- •Past or present diagnoses of cardiovascular, renal or liver disease
- •Known hypersensitivity to the active treatments
- •Exacerbation of asthma symptoms within the previous 4 weeks
- •Inability to perform the required breathing technique and blood sampling
- •Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
- •Lower respiratory tract infection within 1 month prior to inclusion
- •Disease (other than asthma) which might influence the outcome of the study
- •Obesity, i.e. > 97% weight percentile by local standards
研究组 & 干预措施
CHF1535 pMDI + AC Plus
Experimental
Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device
干预措施: CHF1535 pMDI + AC Plus (Drug)
BDP and Formoterol + AC Plus
Active Comparator
Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
干预措施: BDP + AC Plus (Drug)
BDP and Formoterol + AC Plus
Active Comparator
Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
干预措施: Formoterol + AC Plus (Drug)
结局指标
主要结局
B17MP AUC0-t
时间窗: pre-dose until 8hours post dose
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
次要结局
- B17MP PK profile(pre-dose until 8 hours post-dose)
- Formoterol PK profile(Pre-dose until 8 hours post-dose)
- Heart rate Time averaged heart rate value (AUC0-t)/t(Pre-dose until 8 hours post-dose)
- Glucose in urine(Pre-dose until 8 hours post-dose)
- BDP PK prolile(Pre-dose until 8 hours post-dose)
- Plasma potassium AUC, Cmin, tmin(Pre-dose until 8 hours post-dose)
- Urinary Cortisol excretion(Pre-dose until 8 hours post-dose)
- Spirometry: PEF(Pre-dose until 8 hours post-dose)
研究者
研究点 (1)
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