Jussi Karjalainen , Ville Vartiainen , Antti Tikkakoski , L. Pekka Malmberg , Liisa Vuotari , Satu Lähelmä , Ulla Sairanen , Mikko Vahteristo , Lauri Lehtimäki
{"title":"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。","authors":"Jussi Karjalainen , Ville Vartiainen , Antti Tikkakoski , L. Pekka Malmberg , Liisa Vuotari , Satu Lähelmä , Ulla Sairanen , Mikko Vahteristo , Lauri Lehtimäki","doi":"10.1016/j.rmed.2024.107693","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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<sub>1</sub>) 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<sub>1</sub> did not recover to at least −10 % of baseline.</p></div><div><h3>Results</h3><p>180 participants (69 % females, mean age 46 yrs [range 18–80], FEV<sub>1</sub>%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<sub>1</sub> difference after the first dose and −0.032 (−0.071) L after the last dose. The differences in FEV<sub>1</sub> 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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":21057,"journal":{"name":"Respiratory medicine","volume":null,"pages":null},"PeriodicalIF":3.5000,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0954611124001677/pdfft?md5=216d15549029bbef30e75fe430f550e8&pid=1-s2.0-S0954611124001677-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Salbutamol Easyhaler provides non-inferior relief of methacholine induced bronchoconstriction in comparison to Ventoline Evohaler with spacer: A randomized trial\",\"authors\":\"Jussi Karjalainen , Ville Vartiainen , Antti Tikkakoski , L. Pekka Malmberg , Liisa Vuotari , Satu Lähelmä , Ulla Sairanen , Mikko Vahteristo , Lauri Lehtimäki\",\"doi\":\"10.1016/j.rmed.2024.107693\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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<sub>1</sub>) 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<sub>1</sub> did not recover to at least −10 % of baseline.</p></div><div><h3>Results</h3><p>180 participants (69 % females, mean age 46 yrs [range 18–80], FEV<sub>1</sub>%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<sub>1</sub> difference after the first dose and −0.032 (−0.071) L after the last dose. The differences in FEV<sub>1</sub> 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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>\",\"PeriodicalId\":21057,\"journal\":{\"name\":\"Respiratory medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-06-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0954611124001677/pdfft?md5=216d15549029bbef30e75fe430f550e8&pid=1-s2.0-S0954611124001677-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Respiratory medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0954611124001677\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Respiratory medicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0954611124001677","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Salbutamol Easyhaler provides non-inferior relief of methacholine induced bronchoconstriction in comparison to Ventoline Evohaler with spacer: A randomized trial
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.
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.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
