Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study
Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study
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DOI：
10.1183/09031936.00187510
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发表时间：
2011-11-01
影响因子：
24.3
通讯作者：
Charlton, B.
中科院分区：
文献类型：
--
作者：
Bilton, D.;Robinson, P.;Charlton, B.
这项吸入干粉甘露醇的国际 III 期研究是一项随机、双盲、为期 26 周的研究，随后又进行了为期 26 周的开放标签 (OL) 扩展。 324 名囊性纤维化 (CF) 患者按 3:2 的比例随机分为甘露醇组（400 mg b.i.d.）和对照组。主要疗效终点是确定双盲阶段 1 秒用力呼气量 (FEV1) 的变化。次要终点包括用力肺活量的变化和肺部病情加重。26 周内，FEV1 显着改善（p
This international phase III study of inhaled dry powder mannitol was a randomised, double-blind, 26-week study, followed by a further 26-week, open-label (OL) extension. 324 cystic fibrosis (CF) patients were randomised, in a 3: 2 ratio, to mannitol (400 mg b.i.d.) and control groups. The primary efficacy end-point was to determine the change in forced expiratory volume in 1 s (FEV1) over the double-blind phase. Secondary end-points included changes in forced vital capacity and pulmonary exacerbations.A significant improvement in FEV1 was seen over 26 weeks (p