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

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Respiratory medicine Pub Date : 2024-06-06 DOI:10.1016/j.rmed.2024.107693

Jussi Karjalainen , Ville Vartiainen , Antti Tikkakoski , L. Pekka Malmberg , Liisa Vuotari , Satu Lähelmä , Ulla Sairanen , Mikko Vahteristo , Lauri Lehtimäki

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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.

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.

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沙丁胺醇简易吸入器与带缓释器的万托林缓释器相比，对甲氧胆碱引起的支气管收缩的缓解效果并无差别：一项随机试验。

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（DPIs）提供了一种替代方法，但人们担心干粉吸入器是否能在阻塞性事件中提供有效的缓解：我们的目的是证明在治疗甲氧胆碱引起的支气管收缩时，沙丁胺醇简易吸入器干粉吸入器与带间隔器的 pMDI 相比无劣效性。同时还评估了布地奈德-福莫特罗简易吸入器 DPI 作为缓解剂的适用性：这是一项随机平行分组试验，受试者被送去进行甲胆碱挑战（MC）测试，以诊断哮喘。一秒钟用力呼气容积（FEV1）至少下降 20% 的受试者被随机分配接受沙丁胺醇缓和吸入剂（2x200 μg）、文托林缓和吸入剂（4x100 μg）或布地奈德-福莫特罗缓和吸入剂（2x160/4.5 μg）作为缓解剂。如果 FEV1 没有恢复到基线的至少-10%，则重复治疗：180名参与者（69%为女性，平均年龄46岁[18-80岁]，FEV1%pred 89.5 [62-142] %）完成了试验。在急性缓解支气管收缩方面，沙丁胺醇简易吸入器的疗效并不优于带间隔器的 pMDI，首次用药后的 FEV1 差值为-0.083（95% LCL -0.146）升，最后一次用药后的 FEV1 差值为-0.032（-0.071）升。布地奈德-福莫特罗简易吸入器与沙丁胺醇 pMDI（带缓释片）在首次用药后的 FEV1 差异为 -0.163 (-0.225) L，在最后一次用药后的 FEV1 差异为 -0.092 (-0.131) L：该研究证实，在缓解急性支气管收缩方面，沙丁胺醇简易吸入器的效果不劣于文托林缓释器，因此，简易吸入器是 MC 试验的一种可持续且安全的缓解剂，并支持在哮喘发作时使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Respiratory medicine 医学-呼吸系统

CiteScore

7.50

自引率

0.00%

发文量

199

审稿时长

38 days

期刊介绍： Respiratory Medicine is an internationally-renowned journal devoted to the rapid publication of clinically-relevant respiratory medicine research. It combines cutting-edge original research with state-of-the-art reviews dealing with all aspects of respiratory diseases and therapeutic interventions. Topics include adult and paediatric medicine, epidemiology, immunology and cell biology, physiology, occupational disorders, and the role of allergens and pollutants. Respiratory Medicine is increasingly the journal of choice for publication of phased trial work, commenting on effectiveness, dosage and methods of action.