Introduction

Most guidelines recommend long-acting bronchodilators over short-acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD). The available evidence for the guidelines was based on dry powder or pressurized metered dose inhalers, but not nebulizations. Nevertheless, there is considerable, poorly evidenced based, use of short acting nebulized bronchodilators.

Methods

This was an investigator initiated, randomized, active controlled, cross-over, double-blind and double-dummy single centre study in patients with stable COPD. The active comparators were indacaterol/glycopyrronium 110/50 μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5 mg via air driven nebulization (SAL/IPR), both given as a single dose on separate days. The primary end point was the area under the FEV₁ curve from baseline till 6 h. Secondary end points included change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity.

Results

A total of 33 COPD patients completed the trial and were evaluable, most of them were ex-smokers. The difference between the tested regimens for the primary endpoint, FEV₁ AUC 0–6 h, 2965 ± 1544 mL (mean ± SD) for IND/GLY versus 3513 ± 1762 mL for SAL/IPR, was not significant (P = 0.08). The peak in FEV1 was higher and was reached faster with SAL/IPR compared to IND/GLY. No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.

Conclusion

Among patients with stable COPD, dry powder long-acting single inhalation of a LABA and a LAMA (IND/GLY) was not superior compared to nebulized short-acting salbutamol plus ipratropium (SAL/IPR) in its bronchodilating effects over 6 h.The effects of the nebulization kicked in faster and peaked higher. The observed differences may be caused by the difference in dosing between the two regimens. The improvement in Borg dyspnoea score did not favour the nebulization. Long-term outcomes were not assessed in this study.

中文翻译：

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在慢性阻塞性肺疾病中，长效双支气管扩张剂治疗（茚达特罗/格隆铵）与雾化短效双支气管扩张剂（沙丁胺醇/异丙托铵）：一项双盲，随机，安慰剂对照试验。

介绍

对于慢性阻塞性肺疾病（COPD）的患者，大多数指南建议长效支气管扩张药优于短效支气管扩张药。该指南的可用证据基于干粉或加压定量吸入器，但不基于雾化剂。尽管如此，仍有大量基于证据不足的短效雾化支气管扩张剂的使用。

方法

这是研究者发起的，针对稳定COPD患者的随机，主动对照，交叉，双盲和双假单中心研究。活性比较剂是通过Breezhaler®（IND / GLY）制成的Inticaterol / glycopyrronium 110/50μg（通过Ulezbro®）（IND / GLY）和通过空气雾化（SAL / IPR）的沙丁胺醇/异丙托溴铵2,5 / 0.5,5 mg，均以单次剂量给药在不同的日子。主要终点是从基线到6小时的FEV ₁曲线下的面积。次要终点包括Borg呼吸困难评分的变化，不良事件和通过吸气能力测得的过度充气变化。

结果

共有33名COPD患者完成了该试验并且可以评估，其中大多数是前吸烟者。主要终点的测试方案之间的差异不明显（IND / GLY为2965±1544 mL ，FEV ₁ AUC 0-6 h，SAL / IPR为2965±1544 mL（平均值±SD），差异无统计学意义（P = 0.08） 。与IND / GLY相比，FEV1的峰值更高，而SAL / IPR达到的更快。在次要终点，包括Borg评分或不良事件，未检测到其他显着差异。

结论

在COPD稳定的患者中，LABA和LAMA干粉长效单次吸入（IND / GLY）在6小时内的支气管扩张作用不如雾化短效沙丁胺醇和异丙托铵（SAL / IPR）好。雾化的效果更快，达到更高的峰值。观察到的差异可能是由两种方案之间的剂量差异引起的。Borg呼吸困难评分的改善不利于雾化。本研究未评估长期结局。