A 2-Part, Randomised, Placebo-Controlled, Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Study Of LAS190792 Delivered By Inhalation In Asthmatic And Chronic Obstructive Pulmonary Disease (COPD) Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Subjects With ≥1 Treatment-emergent Adverse Event
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of LAS190792 to produce bronchodilation (opening of the airways).
详细描述
This study is an integrated Phase I protocol divided into 2 parts.
Part one: a single ascending dose study (6 LAS190792 dose levels) in 16 male subjects with mild asthma. LAS190792 will be administered (by the Genuair® inhaler) under supervision at the study centre, according to the randomisation scheme. One dose level will be administered per week with 2 to 3 weeks between each dose level for the safety and pharmacokinetic data review.
Part two: A 5-way , crossover, single dose study (of LAS190792 [two doses], indacaterol, tiotropium and placebo) in 40 male and non-childbearing potential women subjects with moderate to severe COPD. Each treatment period will be separated by a washout period of at least 7 to 14 days. The aim is to ensure at least 30 subjects complete Part 2 of the study. The primary comparison for bronchodilation will be between LAS190792 doses and placebo. Other treatment comparisons (indacaterol or tiotropium vs placebo and LAS190792 vs indacaterol or tiotropium) will be considered additional.
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LAS190792 Dose 1 (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 1 (Drug)
LAS190792 Dose 2 (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 2 (Drug)
LAS190792 Dose 3 (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 3 (Drug)
LAS190792 Dose 4 (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 4 (Drug)
LAS190792 Dose 5 (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 5 (Drug)
LAS190792 Dose 6 (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 6 (Drug)
Placebo (Part 1)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: Placebo (Drug)
LAS190792 Dose 1 (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 1 (Part 2) (Drug)
LAS190792 Dose 2 (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: LAS190792 Dose 2 (Part 2) (Drug)
Tiotropium 18 μg
Single dose, oral inhalation by HandiHaler® single-dose DPI
干预措施: Tiotropium 18 μg (Drug)
Indacaterol 150 μg
Single dose, oral inhalation by Breezhaler® single-dose DPI
干预措施: Indacaterol 150 μg (Drug)
Placebo (Part 2)
Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
干预措施: Placebo (Drug)
结局指标
主要结局
Subjects With ≥1 Treatment-emergent Adverse Event
时间窗: 30 Days
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)
时间窗: Day 2
Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Up to 36 hours after investigational product administration)
- Time to Maximum Observed Plasma Concentration (Tmax)(Up to 36 hours after investigational product administration)
- Area Under the Concentration-time Curve From Zero to the Time of the Last Measurable Concentration(Up to 36 hours after investigational product administration)