Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device Versus the Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adults Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
研究概览
简要总结
The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female patients aged 18-65 years included.
- •Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening.
- •Patients already treated with a dose of BDP or equivalent up to 2000 µg/day.
- •FEV1 ≥ 60% of predicted for the patient's normal value at screening and randomisation
排除标准
- •Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
- •Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation.
- •Lower respiratory tract infection within one month prior to screening.
- •Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines.
- •Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion.
- •Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening.
- •Any enzyme inducing or inhibiting drug (from 8 weeks before screening visit)
- •Patients who received any investigational new drug within the last 8 weeks before the screening. The patients cannot participate in another clinical study at the same time as the present study.
- •Blood donation (450 mL or more)or significant blood loss less than 12 weeks before the first intake of study drug.
研究组 & 干预措施
Clenil® Modulite® via AeroChamber Plus™
Clenil® Modulite® administered via AeroChamber Plus™ spacer
干预措施: Clenil® Modulite® via AeroChamber Plus™ (Drug)
Clenil® Modulite® via Volumatic™
Clenil® Modulite® administered via Volumatic™ spacer
干预措施: Clenil® Modulite® via Volumatic™ spacer (Drug)
Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block
干预措施: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block (Drug)
Clenil® Modulite® via Volumatic™ plus charcoal block
Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
干预措施: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block (Drug)
结局指标
主要结局
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
时间窗: 0-12 hours
Plasma Cmax,ss for B17MP
次要结局
- evaluation of the pharmacokinetic profile of BDP(0-12 hours)
- Vital signs assessment(from screening (week -1) to week 8)
- haematology and blood chemistry assessment(at screening (week - 1) and week 8)
- Number of patients with Adverse events(during the 11 weeks of study)
- FEV1 predose assessment(from screening (week-1) to week 8)