A Phase II, Monocentric, Open, Randomized, 6-way Cross-over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate 100/6 mcg and 200 mcg) Administered With and Without Activated Charcoal in Adult Asthmatic Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Formoterol AUC0-t and B17MP AUC0-t
研究概览
简要总结
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.
At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
- •Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
- •Patients with Forced Expiratory Volume in 1 sec (FEV1) >= 70 % of predicted values
- •Non or ex-smokers
- •Body Mass Index (BMI) >= 18.5 and <= 32 kg/m2
排除标准
- •Pregnant or lactating women unless using acceptable methods of contraception
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- •History of near fatal asthma
- •Patients with abnormal QTcF at screening Visit
- •Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
- •Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
- •History of drug addiction or excessive use of alcohol ;
- •Diagnosis of restrictive lung disease.
- •Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
- •Significant medical history or any laboratory abnormality indicative of a significant underlying condition
研究组 & 干预措施
NEXThaler 100/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg
干预措施: NEXThaler 100/6 mcg DPI (Drug)
NEXThaler 200/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg
干预措施: NEXThaler 200/6 mcg DPI (Drug)
NEXThaler placebo
Single dose (4 inhalations)
干预措施: NEXThaler placebo (Drug)
NEXThaler 100/6 mcg plus CB
Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg
干预措施: NEXThaler 100/6 mcg DPI (Drug)
NEXThaler 200/6 mcg plus CB
Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg
干预措施: NEXThaler 200/6 mcg DPI (Drug)
Flixotide Accuhaler 500 mcg
Single dose (2 inhalations) of fluticasone propionate
干预措施: Flixotide Accuhaler 500 mcg (Drug)
结局指标
主要结局
Formoterol AUC0-t and B17MP AUC0-t
时间窗: from predose until 12 hr post dose
次要结局
- Other PK parameter of B17MP and formoterol(from predose until 12 hours postdose)
- BDP pharmacokinetic (PK) parameters(from predose until 12 hr post dose)