EUCTR2011-001801-29-SK进行中（未招募）1 期
A single dose, randomised, placebo-controlled, double-blind, 5-way crossover (employing an incomplete block design), efficacy (including 24-h pulmonary function tests) and safety comparison of Tiotropium/BI 54903 FDC ethanolic inhalation solution via Respimat® (doses of 1.23 µg/363.6 µg, 2.46 µg/363.6 µg or 4.93 µg/363.6 µg) versus free combination of Tiotropium aqueous inhalation solution via Respimat® (doses of 0, 2.5 µg, 5 µg or 10 µg) plus BI 54903 ethanolic inhalation solution via Respimat® (dose of 363.6 µg ) in patients with asthma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Outpatients of either sex, aged 18-75 years (inclusive).
- •Never-smokers or ex-smokers (for at least 1 year) with a smoking history of < 10 pack-years.
- •Diagnosis of stable asthma on low-dose or medium-dose inhaled corticosteroids (ICS) with or without long-acting ß2-adrenergic agonists (LABA), GINA treatment steps 2-4.
- •A pre-bronchodilator FEV1 = 50 – 90% predicted.
- •Asthma Control Questionnaire-6 (ACQ-6) < 1.5
- •FEV1 reversibility of = 12% above baseline and an absolute change of = 200 ml within 30 minutes after administration of 400 µg of salbutamol MDI (100 µg per puff).
- •FEV1 reversibility (= 12% above baseline and an absolute change of = 200 ml) within 45 minutes after administration of 80 µg of ipratropium bromide MDI (20 µg per puff).
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •-Patients with a recent history (i.e. six months or less) of myocardial infarction.
- •-Patients requiring more than 8 puffs of salbutamol MDI on at least 2 or more consecutive days during the run-in period.
- •-Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the firs screening visit (Visit 1).
- •-Patients who have been hospitalised for cardiac failure during the past year.
- •-Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
- •-Patients with lung diseases other than asthma (e.g. COPD).
- •-Patients with known active tuberculosis.
- •-Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1.
- •-Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years.
- •-Pregnant or nursing woman.
- •-Women of childbearing potential not using a highly effective method of birth control.
- •-Patients who have taken an investigational drug within four weeks prior to Visit 1.
- •-Patients with known hypersensitivity to anticholinergic drugs, ciclesonide or any other component of the trial medications.
- •-Patients with any asthma exacerbation or any lower or upper respiratory tract infection 4 weeks prior Visit 1.
- •-Patients who have previously been randomised in this trial or are currently participating in another trial.
- •-patients treated with oral corticosteroid, long-acting anticholinergic agent, beta-blocker medication 4 weeks prior Visit 1 or cromone, methylxanthines 2 weeks before Visit 1, or Anti-IgE antibodies 6 months prior Visit 1.
研究者
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