A SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 3-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) WITH OR WITHOUT SPACER DEVICE VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE pMDI AND FORMOTEROL pMDI IN ASTHMATIC ADOLESCENT PATIENTS AND ONE OPEN ARM FOR ADULT PATIENTS AS CONTROL GROUP TREATED WITH CHF 1535 100/6 pMDI.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC0-t of B17MP CHF 1535 100/6 pMDI with and without spacer vs free combination of BDP pMDI and formoterol pMDI
研究概览
简要总结
This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally compared to the systemic exposure in adults without the spacer device.
详细描述
The proposed clinical pharmacology study is aimed to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI (to reach a total dose of BDP 400 µg and formoterol 24 µg) with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products (to reach the same total dose of BDP and formoterol) in adolescent asthmatic patients. The systemic exposure to BDP/B17MP and formoterol after inhalation of CHF 1535 pMDI in adolescents will be additionally compared to the systemic exposure in adults without the spacer device.
The chosen doses correspond to the maximum daily dose of the two components administered as fixed combination.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CHF 1535 100/6 pMDI (Foster®) TEST 1
Adolescents CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
干预措施: Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1 (Drug)
CHF 1535 100/6 pMDI (Foster®) AeroChamber Plus™ (TEST 2).
CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ spacer device in adolescents (TEST 2)
干预措施: CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2). (Drug)
(Qvar®: BDP 400 µg)+(Atimos®: formoterol 24 µg)
BDP 100 µg pMDI, 4 puffs (Qvar®, total dose: BDP 400 µg) + formoterol fumarate 6 µg pMDI, 4 puffs (Atimos®, total dose: formoterol 24 µg)
干预措施: BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF) (Drug)
CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
Adults CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
干预措施: CHF 1535 100/6 pMDI (Foster®) (CTR) (Drug)
结局指标
主要结局
AUC0-t of B17MP CHF 1535 100/6 pMDI with and without spacer vs free combination of BDP pMDI and formoterol pMDI
时间窗: : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.
In adolescents, the systemic exposure of B17MP as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) vs already licensed free combination of BDP pMDI and formoterol pMDI without spacer.
次要结局
- AUC0-t, AUC0-inf, Cmax, tmax and t½ for BDP and formoterol(: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.)
- AUC0-0.5h, AUC0-inf, Cmax, tmax and t½ for B17MP(: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.)
- plasma glucose and plasma potassium AUC0-t; Cmin; Tmin; Cmax; Tmax(: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.)
- Heart rate as AUC0-8h of CHF 1535 100/6 pMDI(pre-dose (within 5 min from dosing), 5 min; 10 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.)
- FEV1; time everaged FEV1 value AUC0-8h; peak FEV1(pre-dose; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.)