NCT01519661已完成4 期
A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis
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
- 157
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths
研究概览
简要总结
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Confirmed diagnosis of Cystic Fibrosis
- •FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
- •Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening
排除标准
- •History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
- •Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
- •History of hearing loss or chronic tinnitus deemed clinically significant
- •Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
- •Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
- •Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
- •Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
- •Use of loop diuretics within 7 days prior to study drug administration
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Tobramycin Inhalation Powder (TIP)
Experimental
Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
干预措施: TBM100 (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths
时间窗: 337 days
Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.
次要结局
- Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted(Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.)
- Relative Change From Baseline in FVC Percent Predicted(Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.)
- Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted(Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.)
- Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum(Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337)
- Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events(Day 337)
- Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa(Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337)
- Number of Days of New Anti-pseudomonal Antibiotic Use(Day 337)
- Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events(Day 337)
- Time to First Hospitalization Due to Serious Respiratory-related Adverse Events(Day 337)
- Percentage of Participants Who Used New Anti-pseudomonal Antibiotics(Day 337)
- Time to Use of New Anti-pseudomonal Antibiotic(Day 337)
研究者
研究点 (1)
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