TY - JOUR T1 - Repeated dose budesonide/formoterol compared to salbutamol in adult asthma: A randomised cross-over trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.02309-2021 SP - 2102309 AU - Nethmi Kearns AU - Pepa Bruce AU - Mathew Williams AU - Marjan Doppen AU - Melissa Black AU - Mark Weatherall AU - Richard Beasley Y1 - 2022/01/01 UR - http://erj.ersjournals.com/content/early/2022/01/20/13993003.02309-2021.abstract N2 - Objective To determine the comparative bronchodilator, systemic beta2-agonist, cardiovascular and adverse effects of salbutamol 200 µg and budesonide/formoterol 200/6 µg when taken repeatedly in stable asthma.Methods This open-label, cross-over, single-centre, controlled trial, randomised adults with asthma to different orders of two treatment regimens: salbutamol 200 µg via MDI at t=0, 30, 60, 90 min, then salbutamol 2.5 mg via nebuliser at t=120, 140, 160 and 420 min; or budesonide/formoterol 200/6 µg one actuation via Turbuhaler at t=0, 30, 60, 90 min, two actuations at t=120, 140, 160 and 420 min. The primary outcome measure was FEV1 after 180 min. Secondary outcomes included repeat measures of FEV1, serum potassium, heart rate, and adverse eventsResults Of 39 patients randomised, two withdrew due to adverse events (QTCF prolongation and T wave abnormalities) after the first intervention with salbutamol. The mean (sd) change from baseline FEV1 180 min after randomisation for salbutamol and budesonide/formoterol regimens was 0.71 (0.46) L, N=38, and 0.58 (0.45) L, N=37, respectively; with a mean (sd) paired difference of −0.10 (0.40) L, N=37, and a model-based estimated difference (95% CI) −0.12 (−0.25 to 0.02) L, p=0.088. In the main secondary analysis, salbutamol resulted in significantly greater FEV1 from 30 to 240 min, but lesser FEV1 at 360 and 420 min. Salbutamol resulted in a significantly lower serum potassium, and a higher heart rate and number of adverse events.Conclusion The comparative bronchodilator responses of repeated administration of salbutamol 200 µg dose−1 and budesonide/formoterol 200/6 µg differed depending on the time of measurement. Salbutamol caused greater systemic beta2-agonist and cardiovascular effects and more adverse events.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of Interest: RB has received research funding from Genentech, Astra Zeneca and Health Research Council New Zealand and personal fees from AstraZeneca, Cipla, Avillion and Theravance all outside the submitted work. All other authors have nothing to disclose outside of the funding for this study. ER -