NCT00885365已完成3 期
A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 43
- 主要终点
- Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal
研究概览
简要总结
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients of either sex aged ≥ 6;
- •Clinical diagnosis of cystic fibrosis defined as: (1)Patients preferably registered in the National Registry of CF (or other documents depending on country legislation); (2) Evidence of two or more typical pulmonary clinical features observed in CF, e.g., persistent colonization/infection with typical CF pathogens, chronic cough and sputum production, persistent chest radiography abnormalities, airway obstruction, nasal polyps and/or digital clubbing;
- •Positive response in the standard sweat test (sweat chloride concentration ≥ 60 mmol/l for the standard method or ≥ 80 mmol/L for a microduct technique) documented in the clinical records and/or gene mutation documented in the clinical records;
- •Chronic colonization of P. aeruginosa: presence in a sputum or throat culture of a minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or presence of more than two precipitating antibodies against P. aeruginosa;
- •Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter ≥ 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition concentration based on microdilution testing system) as identified by local laboratory at screening visit;
- •Forced expiratory volume in 1 sec (FEV₁) ≥ 40% and ≤ 80% of the predicted normal value;
- •Written informed consent obtained by parents/legal representative according to local regulations) and by the patient (when appropriate).
排除标准
- •Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks;
- •Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
- •Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
- •Sputum culture containing Burkholderia cepacia;
- •Patients with end-stage lung disease, candidates for heart-lung transplantation;
- •History of other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose sequelae and/or treatment can interfere with the results of the present study;
- •Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e., contraceptive methods other than rod containing a hormone that prevents user from getting pregnant and that will be placed under the skin, syringes that contain a contraceptive hormone, combined birth control pill, i.e., such that contains two hormones, some intrauterine devices (IUDs) and sexual abstinence). A pregnancy test in urine is to be carried out in women of a fertile age at screening and at the last clinic visit;
- •Known hypersensitivity to aminoglycosides;
- •Patients with evidence of alcohol or drug abuse, likely to be not compliant with the study protocol or likely to be not compliant with the study treatments;
- •Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.
研究组 & 干预措施
Bramitob
Experimental
tobramycin / Bramitob administered 300mg twice a day for 4 weeks
干预措施: tobramycin / Bramitob (Drug)
TOBI
Active Comparator
tobramycin / TOBI administered 300mg twice a day for 4 weeks
干预措施: tobramycin / TOBI (Drug)
结局指标
主要结局
Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal
时间窗: Day 0 (baseline), Week 4
Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.
次要结局
- Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)(Day 0 (baseline), Week 2, Week 4, Week 8)
- Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa(Week 4, Week 8)
- Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal(Day 0 (baseline), Week 2, Week 4, Week 8)
- Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight(Day 0 (baseline), Weeks 2, 4 and 8)
- Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)(Day 0 (baseline), Weeks 2, 4 and 8)
- Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal(Day 0 (baseline), Week 2, Week 4, Week 8)
- Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)(Day 0 (baseline), Week 2, Week 4, Week 8)
- Microbiological Outcome Summary by Visit(Day -10 to -1 (screening), Weeks 4 and 8)
- Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal(Day 0 (baseline), Week 2, Week 4, Week 8)
- Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum(Day -10 to -1 (baseline), Week 4, Week 8)
- Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)(Day 0 (baseline), Week 2, Week 4, Week 8)
- Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa(Week 4, Week 8)
- Count of Participants With Treatment-Emergent Adverse Events (TEAEs)(Day 0 to Week 8)
- Participants With a Hearing Threshold >20 Decibel in at Least One Ear(Day -10 to -1 (screening), Weeks 4 and 8)
研究者
研究点 (43)
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