NL-OMON34341已完成3 期
A phase III multicenter, randomized, parallel, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in the treatment of bronchiectasis. - DPM-B-305
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
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. Have given a written informed consent to participate in this study in accordance with local regulations
- •2. Confirmed diagnosis of (non-cystic fibrosis) bronchiectasis (diagnosed by CT, HRCT, or bronchogram)
- •3. Aged 18*85 years, male and female
- •4. FEV1 >40 and *85 % predicted and > 1.0L
- •5. Clinician documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to Visit 0A and a total of at least 4 in the last 2 years prior to Visit 0A
- •6. Total SGRQ score of *30 at Visit 0B
- •7. 24 hour sputum weight *10g at Visit 0B
排除标准
- •1. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration)
- •2. Be considered *terminally ill* or listed for transplantation
- •3. Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter at any time during the study
- •4. Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic therapy accepted)
- •5. Have smoked within the last 3 months and must not smoke during their participation in the study
研究者
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