CTRI/2011/09/002020已完成3 期
A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1.
Novartis Healthcare Pvt Ltd1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年9月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis.
研究概览
简要总结
Purpose of Study: This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 (CTRI/2010/091/001399) and extension study one CTBM100C2303E1(CTRI/2011/04/001664) (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
FPFV: 19-Sept-2011
Enrollment Target for India: 01
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 21.00 Year(s)（—）
- 性别
- All
入选标准
- •Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study Confirmed diagnosis of cystic fibrosis patients with P.
- •aeruginosa infection.
- •FEV1 at screening (at start of study CTBM100C2303) must be between 25 percentage and 80 percentage of normal predicted values.
排除标准
- •Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.
- •Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
结局指标
主要结局
Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis.
时间窗: Each visit during the 168-day treatment period
次要结局
- 1.Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile.(2.Density of microorganisms in sputum samples)
研究者
研究点 (1)
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