Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Change in P. Aeruginosa Density
研究概览
简要总结
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.
详细描述
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days
干预措施: Placebo (Drug)
MP-376 120 mg QD
MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days
干预措施: MP-376 (Drug)
MP-376 240 mg QD
MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days
干预措施: MP-376 (Drug)
MP-376 240 mg BID
MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days
干预措施: MP-376 (Drug)
结局指标
主要结局
Change in P. Aeruginosa Density
时间窗: from baseline to end of treatment (28 days)
Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period
次要结局
- Percent Change in Forced Expiratory Volume in 1 Second (FEV1)(from baseline to end of the 28-day treatment period (28 days))
- Time to Administration of Other Anti-pseudomonal Antimicrobials(from baseline until final study visit (up to 56 days))
- Change in FEV1 Percent Predicted(from baseline to the end of the treatment 28-day treatment period (28 days))
- Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)(from baseline to the end of the 28-day treatment period (28 days))
- Changes in Susceptability Patterns of Isolated Organisms(from baseline until the end of the 28-day treatment period (28 days))