EUCTR2005-005615-21-NL进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 µg (2 actuations of 2.5 µg) and µg (2 actuations of 5 µg)] of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler as Add-on Therapy in Patients with severe persistent Asthma.
Boehringer Ingelheim bv0 个研究点目标入组 115 人开始时间: 2006年10月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients (male or female) must have a history of frequent (nocturnal) asthma symptoms (episodic breathlessness, wheezing, chest tightness).
- •2.Patients must have a 5-yr history of asthma and a current diagnosis of severe, persistent asthma and must meet the following spirometric criteria:
- •Post bronchodilator (30 min following inhalation of 400 µg salbutamol) FEV1 < 80% of predicted and FEV1 < 70% of FVC (At visit 1).
- •3.Patients must be symptomatic and at least 6 weeks on a high, stable dose of inhaled corticosteroids + a long-acting beta adrenergic (additional sustained release theophylline and/or leukotriene modifier and/or oral glucocorticosteroids are allowed in stable doses)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with a significant disease other than asthma (i.e. (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study)
- •2.Patients with clinically relevant abnormal baseline haematology or blood chemistry will be excluded.
- •3.Patients with a recent history (i.e., six months or less) of myocardial infarction.
- •4.Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year.
- •5.Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
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