A Randomised, Open-label, 2-group PK (3-period) and PD (5-period) Crossover Study to Compare Systemic Exposure and Pharmacodynamic Effects of Fluticasone/Formoterol BAI and pMDI in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).
研究概览
简要总结
A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.
详细描述
Group 1 will assess pharmacokinetics, Group 2 will assess pharmacodynamics. PK interim analysis to determine requirement for PK extension.
Group 1 (PK) blood sampling and safety assessments up to 36 hours post-dose for 3 study periods. Results from PK stage will determine if Group 2 (PD) is required. Group 2 (PD) will assess LABA only effects (as confirmed in interim analysis).
Group 2 (PD) to include 2 overnight stays for 5 study periods. Volunteers will receive a single dose of study medication, with discharge on Day 2.
Study treatments are fluticasone/formoterol BAI, fluticasone/formoterol pMDI with/without spacer, formoterol alone without spacer, and low dose fluticasone/formoterol without spacer.
Volunteers will undergo blood sampling, and safety assessments up to the morning of discharge. An inspiratory flow recorder (IPR) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 18 years or over.
- •Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
- •Normal lung function (FEV1 >90% of predicted normal value).
- •Demonstrate satisfactory technique in the use of the study drug devices.
- •No use of steroid medication (systemic or topical) within 8 weeks prior to study screening.
排除标准
- •Subjects who use any asthma medication or are knowingly regularly exposed to asthma medication.
- •Any history of drug or alcohol abuse.
- •Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- •History of asthma, COPD, or other bronchial or lung diseases.
- •User of steroid medication (systemic or topical) within 8 weeks prior to study screening.
研究组 & 干预措施
Test Treatment
Fluticasone/formoterol 125/5 µg BAI
干预措施: Fluticasone/formoterol BAI (Drug)
Active Comparator 1
Fluticasone/formoterol 125/5 µg pMDI with spacer
干预措施: Fluticasone/formoterol PMDI with spacer (Drug)
Active Comparator 2
Fluticasone/formoterol 125/5 µg pMDI without spacer
干预措施: Fluticasone/formoterol PMDI without spacer (Drug)
Active Comparator 3
Fluticasone/formoterol pMDI (125/5 μg) without spacer, low dose
干预措施: Fluticasone/formoterol PMDI without spacer low dose (Drug)
Active Comparator 4
Formoterol (12 µg) without spacer
干预措施: Formoterol (Drug)
结局指标
主要结局
Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).
时间窗: Pre dose to 36 hours post dose
Serum Potassium
时间窗: Pre Dose to 6 hours post first dose
Maximum reduction in serum potassium from pre-dose.
次要结局
- Vital Signs(Pre Dose to 6 hours post dose)
- Serum Glucose(Pre Dose to 6 hours post dose)