A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
研究概览
简要总结
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with asthma
- •Aged 18 or above
- •Patients using inhaled corticosteroid (with or without long acting beta agonist)
- •Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist
排除标准
- •Asthma exacerbations in previous 6 months
- •COPD or other pulmonary disease
- •Excessive use of short acting beta agonists
研究组 & 干预措施
75 µg Indacaterol (LB) + Placebo (PoS)
75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: 75 µg indacaterol maleate (LB) (Drug)
75 µg Indacaterol (LB) + Placebo (PoS)
75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: placebo to indacaterol (PoS) (Drug)
75 µg Indacaterol (PoS) + Placebo (LB)
75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: 75 µg indacaterol maleate (PoS) (Drug)
75 µg Indacaterol (PoS) + Placebo (LB)
75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: placebo to indacaterol (LB) (Drug)
37.5 µg Indacaterol (PoS) + Placebo (LB)
37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: 37.5 µg indacaterol maleate (PoS) (Drug)
37.5 µg Indacaterol (PoS) + Placebo (LB)
37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: placebo to indacaterol (LB) (Drug)
Placebo (LB) and Placebo (PoS)
Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: placebo to indacaterol (LB) (Drug)
Placebo (LB) and Placebo (PoS)
Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
干预措施: placebo to indacaterol (PoS) (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
时间窗: Day 8
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
次要结局
- Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment(Day 2)
- Number of Participants With Adverse Events as a Measure of Safety(Up to 101 days)
- Peak FEV1 at Day 1 and Day 7(Day 1, Day 7)
- Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8(Day 7, Day 8)
- Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2(Day 1, Day 2)
- Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)(Day 1, Day 7)
- Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2(Day 1, Day 2)
- FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2(Day1, Day 2)
- Number of Puffs of Rescue Medicine(Up to 101 days)
- Time to Peak FEV1 at Day 1 and Day 7(Day 1, Day 7)
- FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8(Day 7, Day 8)
- Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8(Day 7, Day 8)
- Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)(Day 1, Day 7)
- Observed Maximum Concentration (Cmax) After Drug Administration(Day 1, Day 7)
- Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)(Day 1, Day 7)
- FEV1 at Each Time-Point on Day 1 and Day 2(Day 1, Day 2)
- FEV1 at Each Time-Point on Day 7 and Day 8(Day 7, Day 8)
- Peak Expiratory Flow Rate in the Morning in the Evening(Up to 101 days)
- Time to Reach Maximum Concentration (Tmax) After Drug Administration(Day1, Day 7)