EUCTR2009-009869-34-ES进行中（未招募）1 期
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. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
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 by a high-resolution CT scan compatible with bronchiectasis at initial diagnosis and greater than 1 course(s) of systemic antibiotics for exacerbations or greater than or equal to 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 greater than or equal to 35 % and less than or equal to 80 %
- •· Pre-treatment sputum sample available (patient must be able to produce a sputum sample with a volume greater than or equal to 10 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 (greater than or equal to 300 cm3 or requiring blood transfusion) in the preceding 4 weeks
- •· Nebulized antibiotics as maintenance therapy within the previous 4 weeks
- •· Antibiotic treatment of an exacerbation within previous 4 weeks
研究者
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