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European Respiratory Society, European Respiratory Journal, 3(60), p. 2102309, 2022

DOI: 10.1183/13993003.02309-2021

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Repeated dose budesonide/formoterol compared to salbutamol in adult asthma: a randomised crossover trial

This paper was not found in any repository, but could be made available legally by the author.
This paper was not found in any repository, but could be made available legally by the author.

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Abstract

BackgroundOur objective was to determine the comparative bronchodilator, systemic β2-agonist, cardiovascular and adverse effects of salbutamol 200 µg and budesonide/formoterol 200/6 µg when taken repeatedly in stable asthma.MethodsThis open-label, crossover, single-centre, controlled trial randomised adults with asthma to different orders of two treatment regimens: salbutamol 200 µgviametered-dose inhaler at 0, 30, 60 and 90 min, then salbutamol 2.5 mgvianebuliser at 120, 140, 160 and 420 min; or budesonide/formoterol 200/6 µg one actuationviaTurbuhaler at 0, 30, 60 and 90 min, then two actuations at 120, 140, 160 and 420 min. The primary outcome measure was forced expiratory volume in 1 s (FEV1) after 180 min. Secondary outcomes included repeat measures of FEV1, serum potassium, heart rate and adverse eventsResultsOf 39 patients randomised, two withdrew due to adverse events (QTCFprolongation and T-wave abnormalities) after the first intervention with salbutamol. The mean±sdchange from baseline FEV1180 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±sdpaired difference of −0.10±0.40 L (n=37) and a model-based estimated difference of −0.12 (95% CI −0.25–0.02) L (p=0.088). In the main secondary analysis, salbutamol resulted in significantly greater FEV1from 30 to 240 min, but lesser FEV1at 360 and 420 min. Salbutamol resulted in a significantly lower serum potassium, and a higher heart rate and number of adverse events.ConclusionsThe comparative bronchodilator responses of repeated administration of salbutamol 200 µg and budesonide/formoterol 200/6 µg differed depending on the time of measurement. Salbutamol caused greater systemic β2-agonist and cardiovascular effects and more adverse events.