A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children
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
- Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP
研究概览
简要总结
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI
详细描述
This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
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 with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
- •Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
- •Age ≥ 5 < 12 years (8 to 10 children in the age range 5-8 years old).
- •Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
- •A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures
排除标准
- •Past or present diagnosis of cardiovascular, renal or liver disease.
- •Known hypersensitivity to the active treatmen
- •Exacerbation of asthma symptoms within 4 weeks prior to screening.
- •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
NEXThaler® 35/4µg
CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg
干预措施: CHF 1535 35/4µg NEXThaler® (Drug)
Reference treatment
Drug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
干预措施: free comb. beclomethasone DPI and formoterol DPI (Drug)
结局指标
主要结局
Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP
时间窗: predose, 15,30min, 1,2,4,6,8 hours post dose
B17MP: Profile of Pharmacokinetics
次要结局
- BDP Cmax(predose, 15min,30min,1,2,4,6,8 hours post dose)
- BDP Tmax(predose, 15min,30min,1,2,4,6,8 hours post dose)
- BDP T1/2(predose, 15min,30min,1,2,4,6,8 hours post dose)
- B17MP Cmax(predose, 15min,30min,1,2,4,6,8 hours post dose)
- Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [(predose, 15min, 30 min, 1,2,4,6,8 hours postdose)
- Formoterol Tmax(predose, 15min, 30 min, 1,2,4,6,8 hours postdose)
- plasma potassium Area Under Curve (AUC)(predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose)
- B17MP Tmax(predose, 15min,30min,1,2,4,6,8 hours post dose)
- BDP Area Under Curve (AUC)(predose, 15min,30min,1,2,4,6,8 hours post dose)
- Formoterol Cmax(predose, 15min, 30 min, 1,2,4,6,8 hours postdose)
- plasma potassium Tmin(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)
- B17MP T1/2(predose, 15min,30min,1,2,4,6,8 hours post dose)
- Formoterol T1/2(predose, 15min, 30 min, 1,2,4,6,8 hours postdose)
- plasma potassium Cmin(predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose)