Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 521
- 主要终点
- Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
研究概览
简要总结
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.
详细描述
Number of participants with Adverse events will be covered in Adverse Events section.
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
- •Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis
- •Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks
排除标准
- •Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted
- •Active allergic bronchopulmonary aspergillosis
- •Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
- •Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
研究组 & 干预措施
Ciprofloxacin DPI 28 Days on/off (Cipro 28)
Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
干预措施: Ciprofloxacin (BAYQ3939) dry powder for inhalation (Drug)
Ciprofloxacin DPI 14 Days on/off (Cipro 14)
Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
干预措施: Ciprofloxacin (BAYQ3939) dry powder for inhalation (Drug)
Placebo 28 Days on/off (Placebo 28)
Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
干预措施: Placebo (Drug)
Placebo 14 Days on/off (Placebo 14)
Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
时间窗: Up to Week 48
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
时间窗: Up to Week 48
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
次要结局
- Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks(Up to Week 48)
- Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)(End of treatment (Week 44/46))
- Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks(Up to Week 48)
- Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)(Baseline and end of treatment (Week 44/46))
- Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)(End of treatment (Week 44/46))
- Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)(Baseline and end of treatment (Week 44/46))
- Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)(Baseline and end of treatment (Week 44/46))