A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI
研究概览
简要总结
The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
- •Written informed consent;
- •Diagnosis of asthma as defined in the GINA guidelines;
- •Patients with stable asthma, according to the Investigator's opinion;
- •Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
- •Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;
- •Patients with a peak inspiratory flow (PIF) > 40 L/min
- •Reversibility test;
- •Non- or ex-smokers;
- •A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;
排除标准
- •Pregnant or lactating female;
- •Having received an investigational drug within 2 months before the screening visit
- •Diagnosis of COPD as defined by the current GOLD guidelines;
- •Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
- •Known hypersensitivity to the active treatments;
- •History of drug addiction or excessive use of alcohol;
- •Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
- •Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
- •Inability to perform the required breathing technique and blood sampling;
- •Lower respiratory tract infection within 1 month prior to the screening visit;
- •Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.
研究组 & 干预措施
CHF1535 NEXT DPI
Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI
干预措施: CHF1535 NEXT DPI (Drug)
Free combination BDP and FF
Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF
干预措施: BDP DPI and formoterol DPI (Drug)
结局指标
主要结局
Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI
时间窗: 0-8hrs
Plasma AUC0-t for B17MP
次要结局
- Different pharmacokinetic parameters(0-8hrs)
- Adverse Events(during the whole study period)
- Lung function parameters(0-8hrs)
- Plasma potassium(0-8hrs)
- Plasma glucose(0-8hrs)
- Heart rate(0-8hrs)