Repeated dose budesonide/formoterol compared to salbutamol in adult asthma: A randomised cross-over trial. Kearns, N., Bruce, P., Williams, M., Doppen, M., Black, M., Weatherall, M., & Beasley, R. European Respiratory Journal, February, 2022.
Repeated dose budesonide/formoterol compared to salbutamol in adult asthma: A randomised cross-over trial [link]Paper  doi  abstract   bibtex   
Objective To determine the comparative bronchodilator, systemic beta 2 -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 FEV 1 after 180 min. Secondary outcomes included repeat measures of FEV 1 , serum potassium, heart rate, and adverse events Results Of 39 patients randomised, two withdrew due to adverse events (QT CF prolongation and T wave abnormalities) after the first intervention with salbutamol. The mean ( sd ) change from baseline FEV 1 180 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 FEV 1 from 30 to 240 min, but lesser FEV 1 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 beta 2 -agonist and cardiovascular effects and more adverse events.
@article{kearns_repeated_2022,
	title = {Repeated dose budesonide/formoterol compared to salbutamol in adult asthma: {A} randomised cross-over trial},
	issn = {0903-1936, 1399-3003},
	shorttitle = {Repeated dose budesonide/formoterol compared to salbutamol in adult asthma},
	url = {http://erj.ersjournals.com/lookup/doi/10.1183/13993003.02309-2021},
	doi = {10.1183/13993003.02309-2021},
	abstract = {Objective
              
                To determine the comparative bronchodilator, systemic beta
                2
                -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 FEV
                1
                after 180 min. Secondary outcomes included repeat measures of FEV
                1
                , serum potassium, heart rate, and adverse events
              
            
            
              Results
              
                Of 39 patients randomised, two withdrew due to adverse events (QT
                CF
                prolongation and T wave abnormalities) after the first intervention with salbutamol. The mean (
                sd
                ) change from baseline FEV
                1
                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 FEV
                1
                from 30 to 240 min, but lesser FEV
                1
                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 beta
                2
                -agonist and cardiovascular effects and more adverse events.},
	language = {en},
	urldate = {2022-03-04},
	journal = {European Respiratory Journal},
	author = {Kearns, Nethmi and Bruce, Pepa and Williams, Mathew and Doppen, Marjan and Black, Melissa and Weatherall, Mark and Beasley, Richard},
	month = feb,
	year = {2022},
	pages = {2102309},
}

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