EUCTR2009-018005-43-PL进行中（未招募）不适用
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 and 5 µg once daily) compared with placebo and salmeterol HFA MDI (50 µg twice daily) over 24 weeks in patients with moderate persistent asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •Diagnosis of moderate persistent asthma.
- •Asthma diagnosis made before age of 40.
- •At least a 3 month history of asthma.
- •Pre-bronchodilator FEV1 = 60% and = 90% of predicted at Visit 1.
- •Increase in FEV1 of = 12% and = 200 mL 15 to 30 min after 400 µg
- •salbutamol (albuterol) at Visit 1.
- •Maintenance treatment with medium dose of inhaled corticosteroids for
- •at least 4 weeks before Visit 1.
- •Symptomatic despite their current maintenance treatment with ICS (ACQ
- •Variation in absolute pre-BD FEV1 values Visit 1 compared to Visit 2
- •within ± 30%.
- •Never-smokers or ex-smokers (stopped at least one year prior to
- •enrolment + smoking history of less than 10 pack years).
- •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 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients with a significant disease other than asthma.
- •Patients with a clinically relevant abnormal screening haematology or
- •blood chemistry if the abnormalitiy defines a significant disease.
- •Patients with a recent history (i.e. six months or less) of myocardial
- •infarction. 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 with malignancy for which the patient has undergone resection,
- •radiation therapy or chemotherapy within the last five years.
- •Patients with treated basal cell carcinoma are allowed.
- •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 within the past two years.
- •Patients who are currently in a pulmonary rehabilitation program or
- •have completed a pulmonary rehabilitation program in the 6 weeks prior
- •to Visit 1 (screening).
- •Pregnant or nursing woman.
- •Women of childbearing potential not using a highly effective method of
- •birth control.
- •Patients with any asthma exacerbation or any respiratory tract infection
- •in the four weeks prior to Visit 1 or during the screening period.
研究者
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