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.
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。