NCT01468272已完成2 期
A Single-dose,Open-label,Randomized,2-way Cross-over,Clinical Pharmacology Study of CHF1535 50/6 NEXT DPI® Fixed Combination of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6µg)Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI 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
- 26
- 试验地点
- 1
- 主要终点
- B17MP (active metabolite of BDP) Area Under Curve (AUC)
研究概览
简要总结
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
详细描述
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.
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 -11y
- •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
- •Children with 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-agonists treatment for a minimum of 4 h prior to each study treatment.
- •A cooperative attitude and ability to be trained about the proper use of DPI 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 screening (visit 1)
- •Lower respiratory tract infection within 1 month prior to screening (visit 1)
- •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
reference treatment
Active Comparator
Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI
干预措施: free comb. beclomethasone DPI and formoterol DPI (Drug)
CHF 1535 NEXT DPI
Experimental
CHF 1535 50/6 NEXT DPI
干预措施: CHF 1535 50/6 NEXT DPI (Drug)
结局指标
主要结局
B17MP (active metabolite of BDP) Area Under Curve (AUC)
时间窗: predose, 15,30min, 1,2,4,6,8 hours post dose
B17MP: Profile of Pharmacokinetics
次要结局
- B17MP Cmax,Tmax,T1/2(predose, 15min,30min,1,2,4,6,8 hours post dose)
- Heart Rate: Time averaged Heart Rate value: AUC0-t/t(predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose)
- Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2(predose, 15min, 30 min, 1,2,4,6,8 hours postdose)
- plasma potassium Area Under Curve (AUC), Cmin, Tmin(predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose)
- BDP Area Under Curve (AUC), Cmax, Tmax, T1/2(predose, 15min,30min,1,2,4,6,8 hours postdose)
- Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).(from predose up to 8 hours postdose)
研究者
研究点 (1)
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