A Randomized, Double-blind, Multicenter, 2-period Single-dose Cross-over Study to Assess the Early Bronchodilation of Glycopyrronium Bromide (44 μg o.d.) Compared to Tiotropium (18 µg. o.d.) in Patients With Moderate to Severe COPD (FAST Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
研究概览
简要总结
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female adults aged ≥40 years
- •Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
排除标准
- •Pregnant or nursing (lactating) women
- •Patients who have a clinically significant laboratory abnormality at run-in
- •Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
- •Patients with any history of asthma
- •Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
- •Patients receiving medications in the classes listed in the protocol as prohibited.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
NVA237 followed by tiotropium
Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
干预措施: NVA237 (Drug)
NVA237 followed by tiotropium
Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
干预措施: Tiotropium (Drug)
NVA237 followed by tiotropium
Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
干预措施: Placebo to tiotropium (Drug)
NVA237 followed by tiotropium
Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
干预措施: Salbutamol (Drug)
Tiotropium followed by NVA237
Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
干预措施: Placebo to NVA237 (Drug)
Tiotropium followed by NVA237
Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
干预措施: Salbutamol (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
时间窗: Day 1
Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).
次要结局
- Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose(Day 1)
- Specific Airway Resistance (sRAW)(Day 1)
- Residual Volume (RV)(Day 1)
- Total Lung Capacity (TLC)(Day 1)
- Inspiratory Capacity (IC)(Day 1)
- Functional Resistance Capacity (FRCpleth)(Day 1)