St. Francis Hospital Medical Center, Hartford, CT 06105, USA.
Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.
We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. Patients with moderate to severe COPD were randomized to ipratropium bromide/albuterol (20/100mcg) Respimat inhaler, ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent Inhalation Aerosol MDI)], or ipratropium bromide (20mcg) Respimat inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV(1)) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV(1) (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat inhaler had comparable efficacy to ipratropium bromide/albuterol MDI for FEV(1) area under the curve at 0-6h (AUC(0-6)), superior efficacy to ipratropium Respimat inhaler for FEV(1) AUC(0-4) and comparable efficacy to ipratropium Respimat inhaler for FEV(1) AUC(4-6). All active treatments were well tolerated. This study demonstrates that ipratropium bromide/albuterol 20/100mcg inhaler administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component ipratropium bromide 20 mcg Respimat inhaler. [Clinical Trial Identifier Number: NCT00400153].
我们比较了通过瑞普特吸入器（一种新型无推进剂吸入器）、氯氟烃（CFC）计量吸入器（MDI）和异丙托溴铵瑞普特吸入器给药的异丙托溴铵/沙丁胺醇在 COPD 患者中的疗效和安全性。这是一项多中心、随机、双盲、双模拟、12 周、平行组、活性对照研究。中度至重度 COPD 患者被随机分为异丙托溴铵/沙丁胺醇（20/100mcg）瑞普特吸入器、异丙托溴铵/沙丁胺醇 MDI[36mcg/206mcg（可必特吸入气雾剂 MDI）]或异丙托溴铵（20mcg）瑞普特吸入器。每种药物每日给药 4 次。在 4 个测试日，每 15 分钟进行一次连续肺活量测定，然后每小时进行一次。主要疗效变量为 12 周时与基线相比的 1 秒用力呼气量（FEV1）变化。共有 1480 名随机治疗患者中的 1209 名完成了研究；大多数为男性（65%），平均年龄 64 岁，平均筛选前支气管扩张剂 FEV1（预测百分比）为 41%。异丙托溴铵/沙丁胺醇瑞普特吸入器在 0-6 小时 FEV1 曲线下面积（AUC（0-6））方面与异丙托溴铵/沙丁胺醇 MDI 具有可比性，在 FEV1 AUC（0-4）方面优于异丙托溴铵瑞普特吸入器，在 FEV1 AUC（4-6）方面与异丙托溴铵瑞普特吸入器具有可比性。所有活性治疗均耐受良好。这项研究表明，每日 4 次给予异丙托溴铵/沙丁胺醇 20/100mcg 吸入器 12 周具有等效的支气管扩张作用，与异丙托溴铵/沙丁胺醇 36mcg/206mcg MDI 相比具有相同的安全性，与单一组分异丙托溴铵 20mcg 瑞普特吸入器相比，显著改善了肺功能。[临床试验标识符编号：NCT00400153]
