A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
研究概览
简要总结
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis
- •Early lower respiratory tract infection with P. aeruginosa,
排除标准
- •Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- •Administration of loop diuretics within 7 days prior to study drug administration.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TOBI (tobramycin inhaled solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
干预措施: TOBI (Drug)
TOBI (tobramycin inhaled solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
干预措施: Placebo (Drug)
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
干预措施: TOBI (Drug)
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
时间窗: Day 29
Sputum/throat swab cultures were assessed.
次要结局
- Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle(Day 91)
- Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period(Day 91)