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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 124
- 主要终点
- Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).
研究概览
简要总结
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.
详细描述
Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during >=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i.e. cough, wheezing, dyspnoea or sputum production) lasting >=3 days.
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-cystic fibrosis idiopathic or post pneumonic bronchiectasis
- •Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days
排除标准
- •Forced Expiratory Volume 1 < 35% or > 80%
- •Allergic bronchopulmonary aspergillosis
- •Immunodeficiency disease requiring immunoglobulin replacement
- •Inflammatory bowel disease
研究组 & 干预措施
Ciprofloxacin Inhale (BAYQ3939)
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
干预措施: Ciprofloxacin (Cipro, BAYQ3939) (Drug)
Placebo
Inhalation of matching placebo twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).
时间窗: Baseline and 29 days
Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of \> 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm
次要结局
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Baseline and up to end of study (planned at Day 84))
- Change From Baseline in Forced Vital Capacity (FVC)(Baseline and up to end of study (planned at Day 84))
- Time to Exacerbation With Antibiotic Intervention(Up to end of study (planned at Day 84))
- Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score(Up to end of study (planned at Day 84))
- Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)(Up to end of study (planned at Day 84))
- Change From Baseline in High Sensitive C-reactive Protein (hsCRP)(Baseline and up to Day 42)
- Change From Baseline in Absolute Neutrophil Count (ANC)(Baseline and up to Day 42)
- 24-hour Sputum Volume(Up to end of study (planned at Day 84))
- 24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)(Up to end of study (planned at Day 84))
- Microbiological Response of Cipro Inhale Per Participant(Up to end of study (planned at Day 84))
- Microbiological Response of Cipro Inhale Per Pathogen(Up to end of study (planned at Day 84))
- Emergence of New Potential Respiratory Pathogens(Up to end of study (planned at Day 84))
- Emergence of Resistance Among Baseline Pathogens(Up to end of study (planned at Day 84))