NCT02657473已完成2 期
Long-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.
Medical Center Alkmaar6 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年8月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Number of exacerbations
研究概览
简要总结
The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.
详细描述
See uploaded study protocol
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
- •Confirmed non-CF bronchiectasis by (HR)CT
- •Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
- •No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
- •Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus within 12 months.
- •Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
- •Tolerance of inhaled tobramycin
排除标准
- •Any exacerbation within the month prior to the start of the study
- •Diagnosis of cystic fibrosis
- •Active allergic bronchopulmonary aspergillosis (ABPA)
- •Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
- •Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
- •Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
- •Change in physiotherapy technique or schedule within 1 month prior to the start of the study
- •Severe immunosuppression or active malignancy
- •Active tuberculosis
- •Chronic renal insufficiency (eGFR < 30 ml/min), use of loop diuretics
- •Have received an investigational drug or device within 1 month prior to the start of the study
- •Serious or active medical or psychiatric illness
- •Pregnancy and child bearing
- •History of poor cooperation or non-compliance
- •Unable to use nebulizers
- •Allergic for tobramycin
研究组 & 干预措施
TIS 300mg once daily
Active Comparator
Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months
干预措施: tobramycin inhalation solution (Drug)
Placebo once daily
Placebo Comparator
Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months
干预措施: Saline 0.9% inhalation solution (Drug)
结局指标
主要结局
Number of exacerbations
时间窗: 13 months
次要结局
未报告次要终点
研究者
W.G.Boersma
Dr.MD.
Medical Center Alkmaar
研究点 (6)
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