NCT00889967已完成2 期
An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 10
- 主要终点
- The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are willing and able to provide written informed consent.
- •Are males or females 18 to 80 year of age, inclusive.
- •Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
- •Confirmation of infection with P. aeruginosa at screening
排除标准
- •Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
- •Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
- •Have a diagnosis of cystic fibrosis..
- •Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
- •Azithromycin
- •Hypertonic saline
- •Bronchodilator medications
- •Oral corticosteroid.
- •Have received an investigational drug or device within 28 days prior to Visit
- •Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.
研究组 & 干预措施
1
Experimental
Ciprofloxacin for Inhalation 100 mg/day by inhalation
干预措施: Ciprofloxacin for Inhalation (Drug)
2
Experimental
Ciprofloxacin for inhalation 150 mg/day by inhalation
干预措施: Ciprofloxacin for Inhalation (Drug)
Placebo
Placebo Comparator
Placebo by inhalation
干预措施: Placebo (Drug)
结局指标
主要结局
The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28.
时间窗: 28 days
次要结局
- Quality of life (QOL)(28 days)
- Safety and tolerability(28 days)
- Time to, number of, severity of, and time to resolve exacerbations(28 days)
- Microbiological efficacy(28 days)
- Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability(28 days)
研究者
研究点 (10)
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