沙美特罗替卡松粉吸入剂与万托林®经储雾罐雾化吸入治疗支气管痉挛的疗效比较: 一项随机试验。

Salbutamol Easyhaler provides non-inferior relief of methacholine induced bronchoconstriction in comparison to Ventoline Evohaler with spacer: A randomized trial.

机构信息

Allergy Centre, Tampere University Hospital, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.

Heart and Lung Center, Helsinki University Hospital, Finland and Faculty of Medicine, University of Helsinki, Finland.

出版信息

Respir Med. 2024 Aug-Sep;230:107693. doi: 10.1016/j.rmed.2024.107693. Epub 2024 Jun 6.

DOI:10.1016/j.rmed.2024.107693

PMID:38851404

Abstract

BACKGROUND

Salbutamol is a cornerstone for relieving acute asthma symptoms, typically administered through a pressurized metered-dose inhaler (pMDI). Dry powder inhalers (DPIs) offer an alternative, but concerns exist whether DPIs provide an effective relief during an obstructive event.

OBJECTIVE

We aimed to show non-inferiority of Salbutamol Easyhaler DPI compared to pMDI with spacer in treating methacholine-induced bronchoconstriction. Applicability of Budesonide-formoterol Easyhaler DPI as a reliever was also assessed.

METHODS

This was a randomized, parallel-group trial in subjects sent to methacholine challenge (MC) test for asthma diagnostics. Participants with at least 20 % decrease in forced expiratory volume in 1 s (FEV) were randomized to receive Salbutamol Easyhaler (2 × 200 μg), Ventoline Evohaler with spacer (4 × 100 μg) or Budesonide-formoterol Easyhaler (2 × 160/4.5 μg) as a reliever. The treatment was repeated if FEV did not recover to at least -10 % of baseline.

RESULTS

180 participants (69 % females, mean age 46 yrs [range 18-80], FEV%pred 89.5 [62-142] %) completed the trial. Salbutamol Easyhaler was non-inferior to pMDI with spacer in acute relief of bronchoconstriction showing a -0.083 (95 % LCL -0.146) L FEV difference after the first dose and -0.032 (-0.071) L after the last dose. The differences in FEV between Budesonide-formoterol Easyhaler and Salbutamol pMDI with spacer were -0.163 (-0.225) L after the first and -0.092 (-0.131) L after the last dose.

CONCLUSION

The study confirms non-inferiority of Salbutamol Easyhaler to Ventoline Evohaler with spacer in relieving acute bronchoconstriction, making Easyhaler a sustainable and safe reliever for MC test and supports its use during asthma attacks.

摘要

背景

沙丁胺醇是缓解急性哮喘症状的基石药物，通常通过压力定量气雾剂（pMDI）给药。干粉吸入器（DPI）是一种替代选择，但人们担心 DPI 在阻塞事件期间是否能提供有效缓解。

目的

我们旨在证明沙丁胺醇 Easyhaler DPI 与带储雾罐的 pMDI 在治疗乙酰甲胆碱诱导的支气管收缩方面具有非劣效性。还评估了布地奈德福莫特罗 Easyhaler DPI 作为缓解药物的适用性。

方法

这是一项在因哮喘诊断而接受乙酰甲胆碱挑战（MC）测试的受试者中进行的随机、平行组试验。FEV1 下降至少 20%的参与者被随机分配接受沙丁胺醇 Easyhaler（2×200μg）、带储雾罐的 Ventoline Evohaler（4×100μg）或布地奈德福莫特罗 Easyhaler（2×160/4.5μg）作为缓解药物。如果 FEV1 未恢复至至少基线值的-10%，则重复治疗。

结果

180 名参与者（69%为女性，平均年龄 46 岁[范围 18-80]，FEV%pred 89.5[62-142]%）完成了试验。沙丁胺醇 Easyhaler 在急性缓解支气管收缩方面与带储雾罐的 pMDI 不劣效，首次给药后 FEV 差值为-0.083（95%可信区间下限-0.146）L，末次给药后差值为-0.032（-0.071）L。布地奈德福莫特罗 Easyhaler 与沙丁胺醇 pMDI 带储雾罐之间的 FEV 差异分别为首次给药后-0.163（-0.225）L 和末次给药后-0.092（-0.131）L。