NCT00277537已完成3 期
A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.
Syntara22 个研究点 分布在 3 个国家目标入组 354 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 22
- 主要终点
- 24 hour sputum clearance
研究概览
简要总结
Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non cystic fibrosis bronchiectasis
- •Have FEV1 50% - 80% predicted and ≥1.0L
- •Have chronic sputum production of >10 mL per day on the majority of days in the 3 months prior to study entry
排除标准
- •Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry
- •Have airway hyperresponsiveness as defined by a positive Aridol challenge
研究组 & 干预措施
1
Experimental
干预措施: Mannitol (Drug)
2
Other
干预措施: placebo (Drug)
结局指标
主要结局
24 hour sputum clearance
时间窗: 24 hours / 12 weeks
Quality of Life SGRQ
时间窗: 12 weeks
次要结局
- bronchial wall thickening and inflammation(12 weeks)
- cough severity(12 weeks)
- bronchiectasis symptoms(12 weeks)
- exercise capacity(12 weeks)
- lung function, including gas transfer(12 weeks)
- antibiotic use(12 weeks)
- adverse events(12 weeks / 12 months)
- haematology, biochemistry,(12 weeks / 12 months)
- sputum microbiology quantitative and qualitative(12 weeks / 12 months)
研究者
研究点 (22)
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