NCT00281567已完成3 期
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
研究概览
简要总结
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
- •FEV1 < 60% predicted
- •FEV1 < 70% of FVC
- •Smoking history of 10 pack-years
排除标准
- •Significant other disease than COPD
- •Recent history of MI (1 year or less)
- •Cardiac arrhythmia requiring drug therapy
- •History of asthma, allergic rhinitis or eosinophil count > 600 mm3
- •Symptomatic prostatic hypertrophy or bladder neck obstruction
- •Known narrow-angle glaucoma
- •Abnormal baseline hematology, blood chemistry or urinalysis
- •History of cancer within last 5 years
- •Life-threatening pulmonary obstruction
- •Cystic fibrosis or bronchiectasis
- •Tuberculosis
- •Pulmonary resection
结局指标
主要结局
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
次要结局
- Individual FEV1and FVC measurements at each time point(up to 28 weeks)
- Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)(baseline until week 28)
- Peak response (FEV1 and FVC) to first dose(within 3 hours to first dose)
- Peak response (FEV1 and FVC) after 4 weeks(within 3 hours after 4 weeks)
- Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients(up to 28 weeks)
- FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks(after 4 weeks)
- Number of patients with 15% response above baseline for each treatment at each timepoint after first dose(at week 4, 12, 20)
- FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks(after first dose and after 4 weeks)
- Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks(at week 8, 16, 24)
- Number of occasions of rescue therapy used as required (p.r.n. salbutamol)(up to 28 weeks)
- Median time to onset of therapeutic response after first dose(after 4 weeks)
研究者
研究点 (3)
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