EUCTR2016-000166-35-NL进行中（未招募）1 期
Effects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice daily (open label) controlled trial. The BATTLE study.
oordwest Ziekenhuisgroep0 个研究点开始时间: 2016年5月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age = 18 years
- •2.The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
- •3.Confirmed non-CF bronchiectasis by (HR)CT
- •4.Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
- •5.No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
- •6.Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus (sensitive for tobramycin!!) within 12 months.
- •7.Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
- •8.Tolerance of inhaled tobramycin
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Any exacerbation within the month prior to the start of the study
- •2.Diagnosis of cystic fibrosis
- •3.Active allergic bronchopulmonary aspergillosis (ABPA)
- •4.Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
- •5.Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
- •6.Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
- •7.Change in physiotherapy technique or schedule within 1 month prior to the start of the study
- •8.Severe immunosuppression or active malignancy
- •9.Active tuberculosis
- •10.Chronic renal insufficiency (eGFR < 30 ml/min)
- •11.Have received an investigational drug or device within 1 month prior to the start of the study
- •12.Serious or active medical or psychiatric illness
- •13.Pregnancy and child bearing
- •14.History of poor cooperation or non-compliance
- •15.Unable to use nebulizers
- •16.Allergic for tobramycin
研究者
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