NL-OMON47248已完成3 期
ong-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. - Inhaled nebulized tobarmycin in non-CF bronchiectasis
Medisch Centrum Alkmaar0 个研究点目标入组 58 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 and/or prednisolone 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 within 12 months.
- •7. Growth of protocol defined pathogens in sputum sensitive to tobramycin at screening visit
排除标准
- •1. 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. Severe immunosuppression or active malignancy
- •8. Active tuberculosis
- •9. Chronic renal insufficiency (eGFR < 30 ml/min)
- •10. Have received an investigational drug or device within 1 month prior to the start of the study
- •11. Serious or active medical or psychiatric illness
- •12. Pregnancy and child bearing
- •13. History of poor cooperation or non-compliance
- •14. Unable to use nebulizers
- •15. Allergic for tobramycin or NaCl 0.9%
- •16. Use of diuretics, urea or mannitol
- •17. Demonstrated heraring impairment, balance disorders or neuromuscular disorders
- •18. Serious active haemoptysis
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