Abstract
Background Our 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.
Methods This open-label, crossover, single-centre, controlled trial randomised adults with asthma to different orders of two treatment regimens: salbutamol 200 µg via metered-dose inhaler at 0, 30, 60 and 90 min, then salbutamol 2.5 mg via nebuliser at 120, 140, 160 and 420 min; or budesonide/formoterol 200/6 µg one actuation via Turbuhaler 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 events
Results 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 of −0.12 (95% CI −0.25–0.02) 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.
Conclusions The 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.
Abstract
The 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, cardiovascular and adverse effects https://bit.ly/3KqWcDm
Footnotes
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This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) with identifier number ACTRN12619001083189. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices), will be available 1 year after publication until a minimum of 5 years after publication. Data will be available to researchers who provide a methodologically sound proposal that has been approved by the study steering committee to achieve the aims outlined in the approved proposal. Data can be obtained through a signed data access agreement. The agreement can be obtained by e-mailing the Principal Investigator: richard.beasley{at}mrinz.ac.nz. The study protocol is available publicly on the ANZCTR website.
Conflict of Interest: R. Beasley has received research funding from Genentech, AstraZeneca and the 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.
Support statement: This trial was funded by AstraZeneca Ltd. The funder had no role in study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received August 23, 2021.
- Accepted January 13, 2022.
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