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 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 (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: