Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
研究概览
简要总结
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.
Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
- •Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
- •Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
- •Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is 30% FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol < FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
- •Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
- •Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
- •Patient whose COPD symptoms and FEV1 values 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 or exercise-induced bronchospasm.
- •Clinically significant respiratory conditions at the time of Inform Consent signature
- •Hospitalisation due to COPD exacerbation within the previous 3 months.
- •Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
- •Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
- •Clinically significant cardiovascular conditions
- •Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- •Presence of narrow-angle glaucoma.
- •QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,
- •Patient who does not maintain regular day/night, waking/sleeping cycles
研究组 & 干预措施
Formoterol 12 μg
Formoterol fumarate 12 μg twice daily
干预措施: Formoterol 12 μg (Drug)
Placebo
Placebo twice daily
干预措施: Placebo (Drug)
Aclidinium 200 μg / formoterol 12 μg
Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
干预措施: Aclidinium 200 μg / formoterol 12 μg (Drug)
Aclidinium 200 μg / formoterol 6 μg
Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
干预措施: Aclidinium 200 μg / Formoterol 6 μg (Drug)
Aclidinium 200 μg
Aclidinium bromide 200 μg twice daily
干预措施: Aclidinium 200 μg (Drug)
结局指标
主要结局
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
时间窗: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
次要结局
- Change From Baseline in Morning Pre-dose FEV1 at Day 14(Day 14)
- Change From Baseline in Morning Peak FEV1 at Day 14(0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14)