EUCTR2009-009869-34-GB进行中（未招募）不适用
Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
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
- •· Adults at least 18 years of age
- •· Pulmonary stable patients with a proven and documented diagnosis of non-CF idiopathic or post pneumonic bronchiectasis (including patients with primary ciliary dyskinesia) by a CT scan compatible with bronchiectasis at initial diagnosis and > 1 course(s) of systemic antibiotics for exacerbations or = 1 hospitalization for i.v. antibiotic treatment for pulmonary exacerbation during last 12 months.
- •· Stable pulmonary status, as indicated by a forced expired volume in 1 second (FEV1, percent of predicted) of = 35 % and = 80 %
- •· Pre-treatment sputum sample available (patient must be able to produce a sputum sample with a volume = 5 mL) that is positive for at least one of the pre-defined pathogens
- •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
- •·FEV 1 (percent of predicted) < 35% or > 80% (post bronchodilator)
- •· Allergic bronchopulmonary aspergillosis (diagnosed radiologically, serologically or clinically)
- •· Immunodeficiency disease requiring immunoglobulin replacement
- •· Non-tuberculosis mycobacteria infection
- •· Rheumatoid arthritis
- •· Recent significant hemoptysis (= 300 cm3 or requiring blood transfusion) in the preceding 4 weeks
- •· Nebulized antibiotics as maintenance therapy within the previous 4 weeks prior to randomization
- •· Antibiotic treatment of an exacerbation or any other infection within previous 4 weeks prior to randomisation
研究者
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