NCT00122434已完成2 期
A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR 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
- 389
- 试验地点
- 43
- 主要终点
- Trough forced expiratory volume (FEV1) response after four weeks of treatment.
研究概览
简要总结
The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 83 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
Trough forced expiratory volume (FEV1) response after four weeks of treatment.
时间窗: 4 weeks
次要结局
- Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol](4 weeks)
- Trough FEV1 response after 1 and 2 weeks(after 1 and 2 weeks)
- Trough FVC response after 1, 2 and 4 weeks(after 1, 2 and 4 weeks)
- FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks(after 0, 1, 2 and 4 weeks)
- Individual FEV1 and FVC measurements at each time point(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)
- Physician's Global Evaluation(4 weeks)
- All adverse events(7 weeks)
- Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)(4 weeks)
- 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)(4 weeks)
- drug plasma concentrations(4 or 7 weeks)
- drug urine concentrations(4 or 7 weeks)
研究者
研究点 (43)
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