NL-OMON34309已完成2 期
Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD) - Tiotropium Respimat PK study 205.458
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, including medication washout and restrictions.
- •2. Male or female patients 40 years of age or older.
- •3. Patients must be current or ex-smokers with a smoking history of at least 10 pack-years.
- •4. All patients must have a diagnosis of COPD (refer to page 22 of study protocol).
- •5. Patients must be able to perform technically acceptable pulmonary function tests.
- •6. Patients must be able to inhale medication in a competent manner from the Respimat and HandiHaler devices.
排除标准
- •1. Significant diseases other than COPD (refer to page 23 of study protocol).
- •2. Patients with a recent history of myocardial infarction.
- •3. Patients with any unstable of life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
- •4. Hospitalisation for cardiac failure during the past year.
- •5. Patients with a history of asthma or who have a total eosinophil count equal to or above 600/mm3.
- •6. Use of systemic corticosteroid medication at unstable doses (less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day.
- •7. Pregnant or nursing women.
研究者
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