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 (FEV1) 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 FEV1 did not recover to at least -10 % of baseline.
RESULTS: 180 participants (69 % females, mean age 46 yrs [range 18-80], FEV1%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 FEV1 difference after the first dose and -0.032 (-0.071) L after the last dose. The differences in FEV1 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.
CONCLUSIONS: 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.
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 (FEV1) 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 FEV1 did not recover to at least -10 % of baseline.
RESULTS: 180 participants (69 % females, mean age 46 yrs [range 18-80], FEV1%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 FEV1 difference after the first dose and -0.032 (-0.071) L after the last dose. The differences in FEV1 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.
CONCLUSIONS: 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，通常通过加压计量吸入器（pMDI）给药。干粉吸入器（DPI）提供了一种替代方案，但人们担心DPI在阻塞性事件期间是否能有效缓解.
目的：我们旨在显示沙丁胺醇EasyhalerDPI与带间隔物的pMDI相比在治疗乙酰甲胆碱诱导的支气管收缩方面的非劣效性。还评估了布地奈德-福莫特罗EasyhalerDPI作为缓解剂的适用性。
方法：这是一个随机的，在接受乙酰甲胆碱激发(MC)试验用于哮喘诊断的受试者中进行平行组试验。在一秒钟内用力呼气量（FEV1）至少减少20％的参与者被随机分配接受沙丁胺醇Easyhaler（2x200μg），带有间隔物（4x100μg）或布地奈德-福莫特罗Easyhaler（2x160/4.5μg）作为缓解剂的VentolineEvohaler。如果FEV1没有恢复到基线的至少-10%,则重复处理。
结果：180名参与者（69%为女性，平均年龄46岁[范围18-80岁]，FEV1%Pred89.5[62-142]%)完成试验。沙丁胺醇Easyhaler在支气管收缩的急性缓解方面不劣于pMDI，在第一次剂量后显示-0.083（95％LCL-0.146）LFEV1差异，在最后一次剂量后显示-0.032（-0.071）L差异。布地奈德-福莫特罗Easyhaler和具有间隔物的沙丁胺醇pMDI之间的FEV1差异在第一次给药后为-0.163（-0.225）L，在最后一次给药后为-0.092（-0.131）L。
结论：该研究证实了沙丁胺醇Easyhaler与带有间隔物的VentolineEvohaler在缓解急性支气管收缩方面具有非劣效性，使Easyhaler成为MC测试的可持续和安全的缓解剂，并支持其在哮喘发作期间的使用。
目的：我们旨在显示沙丁胺醇EasyhalerDPI与带间隔物的pMDI相比在治疗乙酰甲胆碱诱导的支气管收缩方面的非劣效性。还评估了布地奈德-福莫特罗EasyhalerDPI作为缓解剂的适用性。
方法：这是一个随机的，在接受乙酰甲胆碱激发(MC)试验用于哮喘诊断的受试者中进行平行组试验。在一秒钟内用力呼气量（FEV1）至少减少20％的参与者被随机分配接受沙丁胺醇Easyhaler（2x200μg），带有间隔物（4x100μg）或布地奈德-福莫特罗Easyhaler（2x160/4.5μg）作为缓解剂的VentolineEvohaler。如果FEV1没有恢复到基线的至少-10%,则重复处理。
结果：180名参与者（69%为女性，平均年龄46岁[范围18-80岁]，FEV1%Pred89.5[62-142]%)完成试验。沙丁胺醇Easyhaler在支气管收缩的急性缓解方面不劣于pMDI，在第一次剂量后显示-0.083（95％LCL-0.146）LFEV1差异，在最后一次剂量后显示-0.032（-0.071）L差异。布地奈德-福莫特罗Easyhaler和具有间隔物的沙丁胺醇pMDI之间的FEV1差异在第一次给药后为-0.163（-0.225）L，在最后一次给药后为-0.092（-0.131）L。
结论：该研究证实了沙丁胺醇Easyhaler与带有间隔物的VentolineEvohaler在缓解急性支气管收缩方面具有非劣效性，使Easyhaler成为MC测试的可持续和安全的缓解剂，并支持其在哮喘发作期间的使用。
