NCT01775137已完成4 期
A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles
研究概览
简要总结
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study
排除标准
- •Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
- •Use of loop diuretics within 7 days prior to entry into the extension study
- •Pregnant or nursing women
- •Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco
研究组 & 干预措施
TBM100
Experimental
TIP 112 mg/b.i.d
干预措施: TBM100 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles
时间窗: Baseline (start of study treatment in core study) to Day 673 (end of the extension study)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.
次要结局
- Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles(Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study))
- Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles(Baseline of core study, Day 673 (end of the extension study))
- Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles(Baseline of core study, Day 673 (end of the extension study))
- Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles(Baseline of core study, Day 673 (end of the extension study))
- Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles(Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study))
- The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.(Baseline of core study, Day 673 (end of the extension study))
- Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles(Baseline of core study, Day 673 (end of the extension study))
- Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles(Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study))
- Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study(Baseline of extension study, Day 673 (end of extension study))
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study(Baseline (start of study treatment in extension study) to Day 673 (end of the extension study))
- Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study(Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study))
- Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study(Baseline of extension study, Day 673 (end of extension study))
- Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles(Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day)
- Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles(Baseline of core study, Day 673 (end of the extension study))
- Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study(Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study))
- Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study(Baseline of extension study, Day 673 (end of extension study))
- Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study(Baseline of extension study, Day 673 (end of the extension study))
- Time to Use of New Anti-pseudomonal Antibiotics in Extension Study(Baseline of extension study, Day 673 (end of extension study))
- Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study(Baseline of extension study, Day 673 (end of extension study))
研究者
研究点 (1)
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