NCT00128440已完成2 期
A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 13
- 主要终点
- forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.
研究概览
简要总结
The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with 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
- Double
入排标准
- 年龄范围
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
- •All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
- •Male or female patients 40 years of age or older.
- •Smoker or ex-smoker with a history of more than 10 pack years.
- •1. Patients with any other significant disease will be excluded.
- •Patients with a history of asthma or allergic rhinitis will be excluded.
排除标准
- 未提供
结局指标
主要结局
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.
时间窗: after 4 weeks
Trough forced expiratory volume (FEV1) response
时间窗: baseline to 24 hours post drug administration
次要结局
- FVC AUC0-6h after 0 and 4 weeks(after 0 and 4 weeks)
- Individual FEV1 and FVC measurements at each time point(4 weeks)
- Trough FVC response after 4 weeks(after 4 weeks)
- Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol](4 weeks)
- Physician's Global Evaluation(4 weeks)
- All adverse events(28 weeks)
- FEV1 and FVC peak response after 0 and 4 weeks(after 0 and 4 weeks)
- Weekly mean pre-dose morning and evening PEFR(4 weeks)
- COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest(4 weeks)
- Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing(28 weeks)
- 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9)(28 weeks)
研究者
研究点 (13)
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