Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and 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
- 79
- 试验地点
- 10
- 主要终点
- Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
研究概览
简要总结
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 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 —（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 ≥
- •Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
- •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 salbutamol is 30% < FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
- •Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
- •Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.
排除标准
- •History or current diagnosis of asthma.
- •Clinically significant respiratory conditions other than COPD 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.
- •Clinically significant cardiovascular conditions
- •Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- •Presence of narrow-angle glaucoma.
- •QTcB) 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
Aclidinium bromide 100 μg bid
Aclidininum bromide 100 μg twice daily by inhalation
干预措施: Aclidinium bromide 100 μg bid (Drug)
Aclidininum bromide 200 μg bid
Aclidininum bromide 200 μg twice daily by inhalation
干预措施: Aclidinium bromide 200 μg bid (Drug)
Aclidininum bromide 400 μg bid
Aclidininum bromide 400 μg twice daily by inhalation
干预措施: Aclidininum bromide 400 μg bid (Drug)
Placebo
Placebo twice-daily by inhalation
干预措施: Placebo (Drug)
Formoterol 12 μg bid
Formoterol 12 μg twice daily by inhalation
干预措施: Formoterol 12 μg bid (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
时间窗: Day 7
次要结局
- Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment(Day 7)
- Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment(Day 7)
- Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment(Day 7)