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

Abstract

<p>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<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. Results: 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. 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.</p>