NCT00239447已完成3 期
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
- 131
- 试验地点
- 11
- 主要终点
- Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
研究概览
简要总结
Non-inferiority of lung function response to Tiotropium inhalation solution compared to 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
- •All patients had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
- •All patients had to have a diagnosis of chronic obstructive pulmonary disease.
- •Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal and FEV1 ≤ 70% of forced vital capacity FVC (Visits 1 and 2).
- •Male or female patients 40 years of age or older.
- •Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
- •Patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (PEFR) measurements, and had to be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.
- •Patients had to be able to inhale medication in a competent manner from the Respimat inhaler, the HandiHaler and from a metered dose inhaler (MDI).
排除标准
- •Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- •Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No.
- •Patients with a recent history (i.e., one year or less) of myocardial infarction.
- •Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.
- •Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
- •Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
- •Patients with known narrow-angle glaucoma.
- •Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm
- •Further exclusion criteria apply
结局指标
主要结局
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
时间窗: at the end of each 4-week period
次要结局
- FEV1 AUC 0-12h and FVC AUC 0-12h response(after 4 weeks)
- Individual FEV1and FVC measurements(during study course of 28 weeks)
- FEV1 AUC 0-3h and FVC AUC 0-3h response(after the first dose, after 4 weeks)
- Tiotropium plasma concentration data and urinary excretion data(at the end of each 4-week period)
- Trough forced vital capacity (FVC) response(after 4 weeks)
- Peak response (FEV1 and FVC)(within 3 hours after first dose, after 4 weeks)
- pre-dose morning and evening peak expiratory flow rate (PEFR)(during study course of 28 weeks)
- Number of occasions of rescue therapy used(during study course of 28 weeks)
- Median time to onset of therapeutic response after first dose (FEV1)(after first dose and after 4 weeks)
- Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks(up to 28 weeks)
研究者
研究点 (11)
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