NCT02104245已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 主要终点
- Time to first pulmonary exacerbation (from baseline)
研究概览
简要总结
This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of non-CF bronchiectasis
- •History of P. aeruginosa respiratory infections
- •At least two pulmonary exacerbations treated with antibiotics in the previous year
排除标准
- •Have a clinical diagnosis of CF
- •Are pregnant
研究组 & 干预措施
Ciprofloxacin dispersion for inhalation
Experimental
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
干预措施: Ciprofloxacin dispersion for inhalation (Drug)
Placebo
Placebo Comparator
Liquid formulation of empty liposomes
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first pulmonary exacerbation (from baseline)
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
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