A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 98
- 试验地点
- 41
- 主要终点
- Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.
研究概览
简要总结
Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
- •Male and female subjects between 6 and 21 years of age at the time of screening.
- •FEV1 at screening must be between 25% and 80% of normal predicted values.
排除标准
- •Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.
次要结局
- Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
- Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
- Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
- Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
- Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,