Pulmonary and Rehabilitation Research Group, Dept of Medicine, Clinical Sciences, University Hospital Aintree, Longmoor Lane, Liverpool, United Kingdom.
Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.
To evaluate the effect of beclomethasone/formoterol versus budesonide/formoterol (non-inferiority) and versus formoterol (superiority) in patients with severe stable chronic obstructive pulmonary disease (COPD).
A double-blind, double-dummy, randomised, active-controlled, parallel-group study. After 4 weeks run-in with ipratropium/salbutamol (40/200 μg, three times daily) patients were randomised to receive beclomethasone/formoterol (200/12 μg pressurised metered dose inhaler), budesonide/formoterol (400/12 μg dry powder inhaler) or formoterol (12 μg dry powder inhaler) twice daily for 48 weeks. Co-primary efficacy variables were change from baseline to 48 weeks in pre-dose morning forced expiratory volume in 1 s (FEV(1)) and mean rate of COPD exacerbations.
Of 718 patients randomised, 703 (232 beclomethasone/formoterol, 238 budesonide/formoterol, 233 formoterol) were in the ITT analysis. Improvement in pre-dose morning FEV(1) was 0.077 L, 0.080 L and 0.026 L for beclomethasone/formoterol, budesonide/formoterol and formoterol respectively (LS mean from the ANCOVA model). Beclomethasone/formoterol was not inferior to budesonide/formoterol (95% CI of the difference -0.052, 0.048) and superior to formoterol (p = 0.046). The overall rate of COPD exacerbations/patient/year was similar and not statistically significantly different among treatments (beclomethasone/formoterol 0.414, budesonide/formoterol 0.423 and formoterol 0.431). Quality of life and COPD symptoms improved in all groups and use of rescue medication decreased. Safety profiles were as expected and treatments well-tolerated.
Beclomethasone/formoterol (400/24 μg) treatment for 48 weeks improved pulmonary function, reduced symptoms compared to formoterol, was safe and well-tolerated in patients with severe stable COPD. Neither of the long-acting β2-agonist/inhaled corticosteroid combinations affected the low exacerbation rate seen in this population.
评估丙酸倍氯米松/福莫特罗（非劣效性）和福莫特罗（优效性）在重度稳定型慢性阻塞性肺疾病（COPD）患者中的疗效。
这是一项双盲、双模拟、随机、活性对照、平行分组研究。在使用异丙托溴铵/沙丁胺醇（40/200μg，每日 3 次）进行 4 周导入期治疗后，患者被随机分配接受丙酸倍氯米松/福莫特罗（200/12μg 压力定量气雾剂）、布地奈德/福莫特罗（400/12μg 干粉吸入器）或福莫特罗（12μg 干粉吸入器），每日 2 次，治疗 48 周。主要疗效变量为基线至 48 周时预剂量晨时用力呼气量（FEV1）和 COPD 加重平均发生率的变化。
718 例随机患者中，703 例（丙酸倍氯米松/福莫特罗 232 例，布地奈德/福莫特罗 238 例，福莫特罗 233 例）进行了意向治疗分析。丙酸倍氯米松/福莫特罗、布地奈德/福莫特罗和福莫特罗的预剂量晨时 FEV1 改善分别为 0.077L、0.080L 和 0.026L（ANCOVA 模型的 LS 均值）。丙酸倍氯米松/福莫特罗与布地奈德/福莫特罗相比无劣效性（差异 95%CI-0.052，0.048），且优于福莫特罗（p=0.046）。治疗组间 COPD 加重/患者/年的总体发生率相似，且无统计学差异（丙酸倍氯米松/福莫特罗 0.414，布地奈德/福莫特罗 0.423，福莫特罗 0.431）。所有组的生活质量和 COPD 症状均得到改善，抢救用药减少。安全性特征符合预期，且治疗耐受良好。
在重度稳定型 COPD 患者中，丙酸倍氯米松/福莫特罗（400/24μg）治疗 48 周可改善肺功能，减轻症状，与福莫特罗相比安全且耐受良好。两种长效β2-激动剂/吸入性皮质类固醇联合治疗并未影响该人群中较低的加重发生率。
