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 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 62
- 试验地点
- 7
- 主要终点
- Change From Baseline in Peak 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 of single doses of inhaled LAS100977 QD in patients with persistent asthma.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients aged 18-70 years (both included).
- •Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- •Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- •FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- •Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
- •Patients on a stable dose and regimen
排除标准
- •Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- •Patients diagnosed with COPD.
- •Recent Respiratory tract infections within 6 weeks before Screening Visit.
- •Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- •Clinically significant respiratory conditions.
- •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
LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
干预措施: LAS100977 0.625 μg (Drug)
LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
干预措施: Salbutamol placebo (Drug)
LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
干预措施: LAS100977 1.25 μg (Drug)
LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
干预措施: Salbutamol placebo (Drug)
LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
干预措施: LAS100977 2.5 μg (Drug)
LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
干预措施: Salbutamol placebo (Drug)
Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
干预措施: Salbutamol 400 μg (Drug)
Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
干预措施: LAS100977 placebo (Drug)
Placebo
Placebo to LAS100977, and placebo to salbutamol
干预措施: Salbutamol placebo (Drug)
Placebo
Placebo to LAS100977, and placebo to salbutamol
干预措施: LAS100977 placebo (Drug)
LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
干预措施: LAS100977 0.313 μg (Drug)
LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
干预措施: Salbutamol placebo (Drug)
结局指标
主要结局
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
时间窗: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. 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 were selected.
次要结局
- Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h)
- Peak Forced Expiratory Volume in One Second (FEV1)(+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose)
- Peak Forced Vital Capacity (FVC)(+15 min, +30 min, +1 h, +2 h, +3 h, +4 h)
- Time to Peak Forced Vital Capacity (FVC)(+15 min, +30 min, +1 h, +2 h, +3 h, +4 h)
- Time to Peak Forced Expiratory Volume in One Second (FEV1)(+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose)
- Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h)
- Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h)
- Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose)
- Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)(Baseline and +23 h and +24 h post-dose)
- Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h)
- Change From Baseline in Peak Forced Vital Capacity (FVC)(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose)
- Change From Baseline to Trough Forced Vital Capacity (FVC)(Baseline and +23 h +24 h post-dose)
- Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h)
- Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h)
- Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint(Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h)