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.
ovartis Healthcare Pvt Ltd0 个研究点目标入组 140 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
研究者
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