ISRCTN49790596已完成不适用
A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin® in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin®
Profile Pharma Ltd (UK)0 个研究点目标入组 144 人开始时间: 2008年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
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
- 性别
- All
入选标准
- •1. Patients of either gender, over 18 years of age
- •2. Non-CF bronchiectasis
- •3. Are known to have grown P. aeruginosa from their sputum at least twice in the previous 12 months
- •4. Have experienced and completed treatment for an exacerbation of bronchiectasis within 21 days of screening
排除标准
- •1. CF bronchiectasis
- •2. Confirmed recent allergic bronchopulmonary aspergillosis
- •3. Immune suppression, hypogammaglobulinaemia, inflammatory bowel disease, primary ciliary dyskinesia or myloproliferative disease
- •4. Bronchoreactivity
- •5. Have used colistimethate sodium in the past, or are taking hypertonic saline, high doses of steroid or anti-tumour necrotising factor alpha (anti-TNFa)
- •6. Have recently started azithromycin
- •7. Female patients who are pregnant or nursing
研究者
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