CTRI/2010/091/001399已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
Novartis HealthCare Pvt Ltd4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Relative change from baseline FEV1 percent predicted compared to placebo
研究概览
简要总结
Purpose of the study:
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
Target number of patients from India is1.
Anticipated date of enrollment for the Indian arm is 15 Oct 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 21.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent given by adult subjects or by the parents/legal guardian on behalf of the subject in combination with the subject’ s assent, if capable of assenting, before any assessment is performed.
- •â€¢ Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to o a quantitative pilocarpine iontophoresis sweat chloride test of > 60 mEq/L; or o identification of well-characterized disease-causing mutations in each CFTR gene; or o an abnormal nasal transepithelial potential difference characteristic of CF.
- •â€¢ Male and female subjects aged 6 years to 21 years of age at the time of screening.
- •â€¢ FEV1 at screening must be ≥ 25% and ≤ 80% of normal predicted values for age, sex, and height based on Knudson criteria.
- •aeruginosa must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- •â€¢ Able to expectorate a sputum sample or to provide a deep-throat cough swab at screening.
- •â€¢ Able to comply with all protocol requirements.
- •â€¢ Use of an effective means of contraception in females of childbearing potential.
- •â€¢ Clinically stable in the opinion of the investigator to be treated according to this protocol.
排除标准
- •* Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening.
- •* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- •Other protocol-defined inclusion/exclusion criteria apply.
结局指标
主要结局
Relative change from baseline FEV1 percent predicted compared to placebo
时间窗: Day 29 of on-treatment period of cycle 1
次要结局
- Safety profile of TIPnew(As reported until 4 weeks post study)
- Pharmacokinetic properties of tobramycin from TIPnew(Days 1 and 29)
- Density of microorganisms in sputum samples(Day 1, 29, 57)
研究者
研究点 (4)
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