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 (FEV ₁ ) 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 ₁ did not recover to at least -10 % of baseline.
Results: 180 participants (69 % females, mean age 46 yrs [range 18-80], FEV ₁ %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 ₁ difference after the first dose and -0.032 (-0.071) L after the last dose. The differences in FEV ₁ 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.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. JK reports payment or honoraria for lectures, presentations or educational events from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Novartis and Orion Pharma and participation on an Advisory Board from GlaxoSmithKline and MSD. VV reports being former employee of Orion Pharma and having received personal consultation and lecture fees from Orion Pharma and having been in sustainability advisory board of Orion Pharma. AT reports payments for lectures or presentations from Chiesi and GlaxoSmithKline and participation on an Advisory Board from Chiesi. LPM reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Chiesi and Orion Pharma. LV reports research grant from Tuberculosis foundation of Tampere. LL reports personal fees for lecturers and/or advisory board meetings from ALK, Astra Zeneca, Berlin Chemie, Boehringer Ingelheim, Chiesi, GSK, Menarini, Orion Pharma and Sanofi. SL, US and MV are employees of Orion Pharma.
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