A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Strengths of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 87
- 试验地点
- 8
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-lactating females aged 40 or older.
- •Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
- •Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
- •Post-salbutamol FEV1/FVC < 70% at screening visit.
- •Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
- •Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
- •Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
排除标准
- •History or current diagnosis of asthma.
- •A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
- •Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
- •Clinically significant respiratory conditions other than COPD condition.
- •Clinically significant cardiovascular conditions.
- •Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- •Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- •Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
研究组 & 干预措施
Arm #2
Single dose, double blind treatment period
干预措施: LAS100977 (Drug)
Arm #3
Single dose, double blind treatment period
干预措施: LAS100977 (Drug)
Arm #4
Single dose, double blind treatment period
干预措施: LAS100977 (Drug)
Arm #5
Single dose, double blind treatment period
干预措施: Reference (Drug)
Arm #6
Single dose, double blind treatment period
干预措施: Placebo (Drug)
Arm #1
Single dose, double blind treatment period
干预措施: LAS100977 (Drug)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
时间窗: Day 2
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
次要结局
- Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)(Day 1)
- Time to Peak Forced Expiratory Volume in One Second (FEV1)(Day 1)
- Absolute Inspiratory Capacity (IC) Values(Up to Day 2)
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1)(Up to Day 2)
- Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve(Day 1)
- Change From Baseline in Inspiratory Capacity (IC)(Up to Day 2)
- Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve(Day 1)
- Change From Baseline in Forced Vital Capacity (FVC)(Up to Day 2)
- Change From Baseline in Peak Forced Vital Capacity (FVC)(Day 1)
- Time to Peak Forced Vital Capacity (FVC)(Day 1)
- Absolute Forced Expiratory Volume in One Second (FEV1) Values(Up to Day 2)
- Absolute Forced Vital Capacity (FVC) Values(Up to Day 2)
- Change From Baseline in Trough Forced Vital Capacity (FVC)(Day 2)